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field_job_employment_type

job_organization_name

city

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<h3>Job Description</h3>
Job Description
🚗 Why us? 
<ul>
<li>
Join a pre-IPO startup with capital, traction and runway ($240M funded | 60X revenue growth in 5 years | $2T+ market size)
</li>
<li>
2024 was a milestone year for Jerry.ai. We delivered nearly 60X revenue growth in 5 years while reaching profitability for the first time in our history
</li>
<li>
Work closely with brilliant leaders and teammates from companies like NVIDIA, Robinhood, Amazon, Meta, ByteDance, Square, and more
</li>
<li>
Opportunity to take us to a $10B business and a household name in the next few years
</li>
<li>
Our growth is driven by forward-thinking technology; Harvard Business Review covered the success of our chatbot less than a year after its launch and Jerry.ai is getting mentioned in many conversations about about our use of GenAI, such as this Forbes article
</li>
<li>
Be immersed in a talent-dense environment, greatly accelerate your learning and career growth
</li>
</ul>
&amp;#x1F4BB; About the opportunity
At Jerry.ai, we've redefined car ownership through our innovative digital solutions. Now, we're expanding our horizons with Propelix, our exciting new subsidiary focused on creating a SaaS platform that makes it easy to build and test advanced chatbots and voice bots.
 We're seeking a purpose-driven Senior Engineer to join our innovative Chatbot Team at Propelix, where you'll be at the forefront of developing a platform that empowers businesses to create, deploy, and optimize AI-powered conversation solutions without extensive technical expertise. This role offers a unique opportunity to fully participate in every phase of product development - from user communication and requirements gathering to development and deployment. You won't just execute tasks; you'll contribute as a product designer and planner while experiencing our vibrant geek culture.
🫵 How you will make an impact
<ul>
<li>
Develop new features for our chatbot/voicebot SaaS platform while maintaining high-quality engineering standards
</li>
<li>
Build tools that simplify chatbot creation, testing, and optimization for our clients
</li>
<li>
Collaborate with product managers and designers to enhance the user experience for non-technical customers
</li>
<li>
Apply your understanding of LLM functionality to optimize conversation flows and responses
</li>
<li>
Help shape the future of Propelix as a leading SaaS solution in the conversational AI space
</li>
<li>
Support junior engineers and foster a culture of continuous learning
</li>
</ul>
🚀 Requirements
<ul>
<li>
6+ years of full-time software development experience with a bachelor's degree or higher in computer science or engineering
</li>
<li>
Knowledge of multiple programming languages (we primarily use JavaScript, React, Node.js - knowledge of these in particular not required)
</li>
<li>
Familiarity with cloud infrastructure (AWS, Azure)
</li>
<li>
Experience with distributed systems or large-scale web applications
</li>
<li>
Startup experience at a high-growth company (nice to have)
</li>
</ul>
Bonus points for LLM experience, CI/CD knowledge, React Native proficiency, and open-source contributions!
Our tech stack 
<ul>
<li>
React for web frontend
</li>
<li>
NodeJS + Typescript for backend development
</li>
<li>
React (mobile app is written in React Native)&nbsp;
</li>
<li>
Hosting infra: AWS
</li>
<li>
SMS: Twilio
</li>
<li>
Push notification: APNS and FCM
</li>
</ul>
While we appreciate your interest and application, only applicants under consideration will be contacted.
Jerry.ai is proud to be an Equal Employment Opportunity employer. We prohibit discrimination based on race, religion, color, national origin, sex, pregnancy, reproductive health decisions or related medical conditions, sexual orientation, gender identity, gender expression, age, veteran status, disability, genetic information, or other characteristics protected by applicable local, state or federal laws. 
Jerry.ai is committed to providing reasonable accommodations for individuals with disabilities in our job application process. If you need assistance or an accommodation due to a disability, please contact us at <a href="mailto:recruiting@jerry.ai" target="_blank">recruiting@jerry.ai</a>
About Jerry.ai:
Jerry.ai is America’s first and only super app to radically simplify car ownership. We are redefining how people manage owning a car, one of their most expensive and time-consuming assets.&nbsp;
Backed by artificial intelligence and machine learning, Jerry.ai simplifies and automates owning and maintaining a car while providing personalized services for all car owners' needs. We spend every day innovating and improving our AI-powered app to provide the best possible experience for our customers. From car insurance and financing to maintenance and safety, Jerry.ai does it all.
We are the #1 rated and most downloaded app in our category with a 4.7 star rating in the App Store. We have more than 5 million customers — and we’re just getting started.&nbsp;
Jerry.ai was founded in 2017 by serial entrepreneurs and has raised more than $240 million in financing.
Join our team and work with passionate, curious and egoless people who love solving real-world problems. Help us build a revolutionary product that’s disrupting a massive market.

Senior Full Stack Engineer

Senior Software Engineer - Conversational AI

<h3>Job Description</h3>
Job Description
JOB SUMMARY:
The Quality Systems Manager will provide overall company leadership and direction for Quality Assurance and Regulatory Affairs Systems, encompassing both improvements and sustaining activities. Objectives involve ensuring patient and employee safety and the achievement of customer quality requirements, create, monitor and improve quality systems/programs, reduce quality costs and maintain compliance within FDA and ISO regulations. The role requires the above to be accomplished within Tecomet principles of continuous improvement, customer driven innovation and a win first culture, while meeting company financial and other performance metrics.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
<ul>
<li>Oversee and implement an advanced level of world-class quality systems for planning, design of experiments (DOE), ISO 13485, quality function development (QFD), design for world-class manufacturability. </li>
<li>Take a leadership role and mentor supporting functional team members.</li>
<li>Integrate the quality function with manufacturing as a value added (real-time) support function, optimizing the continuous quality improvement process, while reducing cost and improving customer relationships.</li>
<li>Design and facilitate the development of quality systems for a highly regulated medical device industry to achieve customer satisfaction, increase productivity and maximize the profit margins for Tecomet. The objective is to devise systems that facilitate good products fast without compromise.</li>
<li>Assure Tecomet is conducting business within compliance to the regulations, as cost effectively and efficiently as possible.</li>
<li>Provide organizational assessments to upper management.</li>
<li>Enhance company systems interface capabilities while optimizing the capabilities to perpetuate harmonized systems improvements through deployment of best practices from the collective experience contribution of the worldwide teams.</li>
<li>Focus on continual quality improvement, while aligned with internal and external customer expectations. The results/objectives are geared on achieving an error-free (flawless) process, which will deliver products on time with world-class quality standards for improving quality, profits and generating new business.</li>
<li>Ensure the organization is basing improvement related decisions on factually/meaningful data, subsequently reducing waste and expediting the recognition of favorable results.</li>
<li>Leadership responsibility for promoting and developing the Tecomet Worldwide Quality Management Systems Software implementation/validation and harmonization (ETQ); New Product Development; and Worldwide Supplier Quality Systems.</li>
<li>Performs other duties or special projects as required or as assigned by supervisor. </li>
</ul>
KNOWLEDGE, SKILLS AND ABILITIES:
<ul>
<li>Strong organizational skills</li>
<li>Strong people and leadership skills</li>
<li>Diplomacy</li>
<li>Motivation</li>
<li>Teaching/Coaching/Mentoring</li>
<li>Verbal and written communication and listening skills</li>
<li>Highly Proficient in Microsoft Office</li>
<li>Problem solving and evaluation</li>
<li>Process improvement</li>
<li>Project management</li>
<li>ISO 13485/EN46001</li>
<li>ISO 14001</li>
<li>Federal and State laws and regulations</li>
<li>Knowledge of International Quality Standards</li>
<li>Strong auditing background</li>
<li>Speak in front of people in a variety of settings</li>
<li>Be flexible and adapt to changes in the marketplace</li>
<li>Create and manage high performing work teams</li>
<li>Interface professionally and courteously with customers/public/internal staff</li>
<li>Meet goals and objectives set for the company</li>
<li>Make decisions in a consistent, professional manner</li>
<li>Maximize opportunities for the business</li>
</ul>
EDUCATION AND WORK EXPERIENCE:
Educational/Training Requirement: 
<ul>
<li>Bachelor of Science in Engineering (ME, IE, BME), preferred</li>
<li>Experience, training and certification may be considered</li>
<li>Master’s degree (desirable but not essential)</li>
</ul>
Experience: 
<ul>
<li>5+ years of Quality Engineering experience within a manufacturing environment required.</li>
<li>Minimum of 2 years of experience related to working within a regulated environment is preferred.</li>
<li>3-5 years working directly with New Product Development and/or related launches, preferred.</li>
</ul>
Licenses/Certifications: 
<ul>
<li>Six Sigma Black Belt certification (desirable but not essential)</li>
<li>ASQ: CBA, CQA and CQE certification, preferred.</li>
</ul>
PHYSICAL AND ENVIRONMENTAL DEMANDS:
<ul>
<li>Mobility to move throughout the production facilities and various sites, and to sit for eight (8) or more hours per day.</li>
<li>Able to communicate quickly and clearly verbally, in writing and by phone.</li>
<li>Able to perform repetitive, highly accurate keyboard operations for eight(8) or more hours per day and on weekends (if required)</li>
<li>Ability to read fine print</li>
<li>Position takes place in a well-lighted, heated/air-conditioned indoor office/production setting with adequate ventilation</li>
<li>Light physical activity performing non-strenuous daily activities of a primarily administrative nature.</li>
<li>Manual dexterity sufficient to reach/handle items and work with fingers </li>
<li>Ability to wear proper PPE. TRAVEL REQUIREMENTS: X YES NO 
<ul>
<li>Travel will be determined as needed.</li>
</ul>
</li>
</ul>
Americans with Disabilities Act (ADA): 
<ul>
<li>Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. </li>
</ul>
Equal Opportunity/Affirmative Action Employer/Protected/ Veterans/Disabilities/Drug Free Workplace

Manager, Quality Systems

<h3>Job Description</h3>
Job Description
CodaMetrix (CMX) is revolutionizing Revenue Cycle Management with its AI-powered autonomous coding solution, a multi-specialty AI-platform that translates clinical information into accurate sets of medical codes. CodaMetrix’s&nbsp; autonomous coding drives efficiency under fee-for-service and value-based care models and supports improved patient care. We are passionate about getting physicians and healthcare providers away from the keyboard and back to clinical care. Overview
The Vice President, Data Platforms is a member of the Data &amp; Analytics team, reporting to the Senior Vice President, Data &amp; Analytics. The Data &amp; Analytics team consists of the Data Engineering, Business Intelligence, Customer Integrations and Data Analysis teams and is responsible for supporting all internal teams who consume data on a regular basis (Engineering, Machine Learning, Analytics, etc. and developing data products for CMX customers. The goal of the team is to develop and execute on the Data &amp; Analytics strategy.
The Vice President, Data Platforms is responsible for maintaining the health of the Databricks Lakehouse platform and ensuring that all required data is sourced proactively and cost-effectively for CMX Machine Learning teams. They are also accountable for all data ingestion, architecture, engineering and sourcing functions.
Responsibilities
<ul>
<li>Own and evolve the Databricks Data Lake platform strategy, architecture, security, and operations.</li>
<li>Lead all data ingestion ETL/ELT, and data integration activities from internal and external sources.</li>
<li>Architect and oversee scalable data pipelines and services to source and curate high-quality datasets for machine learning, analytics, and business intelligence use cases.</li>
<li>Collaborate closely with machine learning, product, data analysis, integrations and engineering teams to prioritize data needs and ensure data availability, quality, and accessibility.</li>
<li>Build, lead, mentor a high-performing data engineering and data architecture team while establishing a robust sourcing function for machine learning.</li>
<li>Establish data governance, metadata management and data quality frameworks.</li>
<li>Optimize cost, performance, and operational efficiency of the data infrastructure.</li>
<li>Ensure compliance with HIPAA, SOC2, and other healthcare data security standards.</li>
<li>Develop and manage budgets, vendor relationships, and technology evaluations related to the data platform ecosystem.</li>
<li>Partner with senior leadership, including the Architecture committee, to align data platform initiatives with company goals and the product roadmap.</li>
<li>Work closely with engineering managers, machine learning, and implementations teams to understand the current state of data acquisition, processing, storage and usage.</li>
<li>Define, document, and communicate the data management lifecycle to all internal data stakeholders and participate as a key member of the Architecture Review Council.</li>
<li>Contribute as a member of the senior leadership team by driving the data initiatives for the company.</li>
</ul>
&nbsp;Requirements&nbsp;&nbsp;
<ul>
<li>Required
<ul>
<li>10+ years of experience in data engineering, data architecture, or data platform leadership roles with 5+ years leading data platform teams.</li>
<li>Expertise managing and scaling cloud-based data platforms particularly Databricks on AWS or Azure.</li>
<li>Deep experience designing and operating large scale data lakes, real-time and batch data pipelines, and streaming architectures.</li>
<li>Strong understanding of ML and AI data sourcing needs (labeled datasets, feature stores, etc.)</li>
<li>Experience working with structured, semi-structured, and unstructured healthcare data (EHR, claims, clinical notes, HL7, FHIR)&nbsp; is highly desirable.</li>
<li>Strong knowledge of modern data technologies (Spark, Delta Lake, Kafka, Airflow, dbt, etc.)</li>
<li>Solid grasp of data security, privacy, and compliance frameworks (HIPAA, SOC2, HITRUST).</li>
<li>Excellent leadership, collaboration, and communication skills, with the ability to influence across technical and business teams.</li>
<li>Bachelor’s or Master’s degree in Computer Science, Engineering, Information Systems or related field; advanced degree preferred.</li>
</ul>
</li>
<li>Preferred
<ul>
<li>Startup and/or Commercial experience</li>
<li>Healthcare Technology experience</li>
<li>Databricks and/or Snowflake experience​​​​​​​</li>
</ul>
</li>
</ul>
The estimated hiring range for this role is $215,000 - $255,000 (plus applicable bonus/plus equity). This hiring range could vary by region based upon local market data. Final salary is ultimately decided upon taking into account a wide range of factors, including but not limited to: skills and experience, licensure and certifications, education, specific location and dynamic market data.
 &nbsp;
What CodaMetrix can offer you: 
Learn more about our full-time employee benefits and how we take care of our team.
<ul>
<li>Health Insurance: We cover 80% of the cost of medical and dental insurance and offer vision insurance</li>
<li>Retirement: We offer a 401(k) plan that eligible employees can contribute to one month after their first day</li>
<li>Flexibility: We have a generous Paid Time Off policy, which is managed but not limited, so you can take the time you need to relax and rejuvenate</li>
<li>Learning: All new hires complete our 7-week Onboarding Program where they learn about our company and each of our departments through live sessions hosted by a variety of our leaders</li>
<li>Development: We provide annual performance evaluations and prioritize working with employees on what their individual growth looks like </li>
<li>Recognition: We recognize the outstanding achievements of our team through annual company awards where employees have the opportunity to nominate their peers</li>
<li>Office Location: A modern open plan workspace located in the bustling Back Bay neighborhood of Boston</li>
<li>Additional Employer Paid Benefits: We offer employer-paid life insurance and short-term and long-term disability insurance</li>
</ul>
Background Check Notice
All candidates will be required to complete a background check upon acceptance of a job offer.
Equal Employment Opportunity
Our company, as well as our products, are made better because we embrace diverse skills, perspectives, and ideas. CodaMetrix is an Equal Employment Opportunity Employer and all qualified applicants will receive consideration for employment.
Don’t meet every requirement? We invite you to apply anyway. Studies have shown that women, communities of color and historically underrepresented talent are less likely to apply to jobs unless they meet every single qualification. At CodaMetrix we are committed to building a diverse, inclusive and authentic workplace and encourage you to consider joining us.
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ZateDhgwSG

Vice President, Data Platforms

<h3>Job Description</h3>
Job DescriptionApply now: QA Complaint Coordinator, Hybrid opportunity local to Bedford, MA. The start date is ASAP for this long-term contract position. Job Title: QA Complaint Coordinator Location: Bedford, MA (3 days/week) Duration: 12 months with opportunity for hire after 6 months Rate: Up to $30/hr W-2 Start Date: ASAP
 Job Summary:
 My client, a leading medical device company, is seeking a dedicated and detail-oriented QA Complaint Coordinator for the postmarket team at a leading medical device company.
 As a Quality Assurance Complaint Coordinator, you will play a crucial role in maintaining and managing the documentation processes for our complaint intake processes. Your meticulous attention to detail and expertise in documentation management will contribute to ensuring compliance with regulatory requirements and quality standards. This position offers an opportunity to work in a fast-paced environment and make a significant impact on patient care.
 Key Responsibilities:
 Document Reviews: Facilitate document reviews by coordinating with subject matter experts, tracking review timelines, and ensuring timely completion of reviews.
 Document Distribution and Training: Manage the distribution of controlled documents, maintain records of document access, and support the training process by ensuring employees are trained on the proper use and understanding of quality documents.
 Document Archiving and Retrieval: Establish and maintain a robust document archiving system to ensure easy retrieval, traceability, and document retention in accordance with regulatory requirements.
 Audit Support: Assist in internal and external audits by providing requested documentation and ensuring all documents are audit-ready.
 Adherence to Regulatory Standards: Stay up-to-date with regulatory requirements, industry trends, and best practices related to document control and quality documentation management.
 Qualifications:
<ul>
<li> Relevant work experience in an administrative capacity, ideally in a medical device company or similar industry</li>
<li> Understanding of quality management systems, document control processes, and regulatory requirements (e.g., FDA, ISO 13485) is a plus</li>
<li> Proficiency in document control software and electronic document management systems.</li>
<li> Excellent organizational skills with exceptional attention to detail.</li>
<li> Strong written and verbal communication skills.</li>
<li> Ability to work independently, manage multiple tasks simultaneously, and meet deadlines.</li>
<li> Collaborative mindset with the ability to work effectively in cross-functional teams.</li>
</ul>

QA Complaint Coordinator

<h3>Job Description</h3>
Job Description
COMPANY DESCRIPTION:
Syner-G Biopharma Group is a science-led, strategic partner for life science companies. We provide integrated regulatory and biopharmaceutical development services spanning early development to post-market, along with operational strategy and support. With a global team of 400 employees across North America and India, our goal is to help our partners navigate the complexities of product development and accelerate their journey to market. 
We are a leading life sciences consultancy committed to advancing human health by helping organizations bring life-saving innovations to market faster, at scale, and with the highest quality. 
Our team partners with a diverse range of clients across the life sciences industry, supporting critical phases of the drug development lifecycle, from discovery and regulatory approval to technology transfer and the support in capital projects. We provide strategic guidance and hands-on expertise to streamline operations, enhance quality systems, and ensure regulatory compliance, empowering our clients to navigate complexity and deliver impactful therapies to patients worldwide. 
Syner-G BioPharma Group was recently honored with BioSpace's prestigious "Best Places to Work" 2025 award, for the second consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership, and innovation.  
At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.  
For more information, visit <a href="http://www.Synergbiopharma.com" target="_blank">www.Synergbiopharma.com</a>
POSITION OVERVIEW:
The Senior Consultant, Quality leads the evaluation of quality events, incidents, and possible complaints and the follow-up of such events. Perform / Lead GMP auditing of manufacturing facilities of clients, vendors, and internal operations as well as ensure that the CMC Quality vertical works seamlessly with Syner-G's Technical group, Regulatory Affairs, CMC leads, and others on the team, as well as key external parties. The Sr Consultant will operate independently, managing day-to-day operations with minimal input or support needed.
WORK LOCATION:
This position is eligible for remote work based on company requirements, with no minimum in-office requirement. Domestic and international travel may be required for this position (Up to 25%).
JOB FUNCTIONS:
(This list is not exhaustive and may be supplemented and changed as necessary.)
<ul>
<li>Work individually and lead others in the Quality business vertical by being the face of the service for Syner-G and our clients.</li>
<li>Collaborate with other business verticals like manufacturing and CMC Technical and Regulatory teams to achieve client needs when appropriate.</li>
<li>Review and approve SOPs, product specifications, batch records, and Annual Product Quality Reports.</li>
<li>Lead / Support development, implementation, and maintenance of the Client's Quality System, including facilitating process improvement activities to the product and project teams for continuous improvement.</li>
<li>Lead / Support Quality System reviews, deviations, OOS, CAPAs, and other remediation plans depending on client needs.</li>
<li>Review the source batch records, COAs, Stability data, and regulatory documentation for the products.</li>
<li>Manage pre-approval inspections by health authorities and internal audits.</li>
<li>Lead / Support building the quality vertical for Syner-G.</li>
<li>Serve as a subject matter expert in areas such as facility cleanroom design, offering guidance and recommendations based on extensive experience.</li>
<li>Act as a liaison between clients and CMOs/Contract labs.</li>
<li>Approve all documents before clinical trials, including creating Certificates of Analysis (COAs) for drug release, expanding accounts from the original Statement of Work (SOW), and providing project components to regulatory bodies such as the FDA.</li>
<li>Possess proficiency in influencing others to achieve objectives, strong problem-solving and critical thinking abilities, comprehensive understanding of all phases of drug development from analytical to manufacturing to commercial, and confidence in leading clients in decision-making processes.</li>
</ul>
QUALIFICATIONS AND REQUIREMENTS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodation may be made to enable individuals with disabilities to perform essential duties.
Education:
A bachelor's or advanced degree (e.g., B.S., M.S., Ph.D.) in biology, biochemistry, chemical engineering, or relevant discipline is required.
Technical Experience:
<ul>
<li>2-5+ years FDA field inspection experience.</li>
<li>10+ years of relevant experience in pharmaceutical industry.</li>
<li>Field inspection experience of small and large molecule pharmaceutical/ biotech companies.</li>
<li>Perform cGMP inspections of finished drug facilities, API manufacturers, contract laboratories.</li>
<li>Conduct Pre-Approval Inspections (PAI) of laboratory facilities.</li>
<li>Familiar with FDA/ORA Investigator practices and procedures.</li>
<li>Knowledge of drug development lifecycle and applied comprehensive understanding of regulations and guidelines to enhance probability of regulatory success and regulatory compliance required.</li>
<li>Working knowledge of cGxPs, ICH and applicable international regulations and guidelines.</li>
<li>Ability to evaluate and follow-up on quality events, incidents and possible complaints.</li>
<li>Understanding of quality system reviews, deviations, OOS, CAPAs and other remediation plans depending on client needs.</li>
<li>Comprehensive understanding of applicable CFR regulations, Regulatory guidelines, quality standards, ICH guidelines, quality management systems initiatives, and industry-specific regulations.</li>
<li>Understanding of computers systems validation methodologies and related industry expectations.</li>
<li>Ability to support the development, implementation, and maintenance of client quality systems including facilitating process improvement activities to the product and project teams.</li>
<li>Adept at applying risk-based and phase-appropriate quality approaches.</li>
</ul>
Knowledge, Skills, and Abilities:
<ul>
<li>Strong Quality Management System knowledge and skills.</li>
<li>Strong time management skills: ability to work under pressure in a fast-paced environment, to coordinate multiple tasks concurrently, adapt to changing priorities, and to meet deadlines.</li>
<li>Excellent project management skills to effectively organize, prioritize, and plan client deliverables.</li>
<li>Effective relationship-building and client management skills, alongside confidence in decision-making and trust-building.</li>
<li>Ability to be adaptable, flexible and develop creative approaches to meet customer needs and improve customer outcomes.</li>
<li>Exceptional stakeholder management skills with the ability to adapt influencing strategies, articulate compelling solutions, uncover client concerns through insightful questioning, and address objections effectively.</li>
<li>Ability to work independently with minimal supervision and problem solve proactively.</li>
<li>Skilled communicator, both written and verbal, who can present ideas and critical information to clients and internal team members effectively and in a concise, organized, impactful manner.</li>
<li>Strong organizational skills and attention to detail.</li>
<li>Demonstrated leadership and management skills.</li>
<li>Strong critical thinking and problem-solving skills: ability to exercise sound reasoning to analyze issues, make decisions, and overcome problems.</li>
<li>Ability to work effectively within a team environment by encouraging collaboration and exhibiting an interpersonal style that is enthusiastic, approachable, and supportive.</li>
</ul>
ESSENTIAL FUNCTIONS:
Physical Demands:
The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.
TOTAL REWARDS:
We define total rewards as compensation, benefits, remote work/flexibility, development, recognition and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work "almost anywhere". However, if a physical work location is more for you, we have office locations in Greater Boston; Boulder, CO; and Chennai, India.
  
LEGAL STATEMENT: Syner-G BioPharma Group is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee's race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G BioPharma is an E-Verify employer.

Senior Consultant, Quality

<h3>Job Description</h3>
Job Description
 
Position Summary
The QA Compliance Specialist I is a quality professional who assists with compliance and quality activities at BSM. The QA Compliance Specialist assists with implementing cGMP and regulatory requirements at BSM. The QA Compliance Specialist is responsible for maintaining and improving the Quality Culture at BSM.
Duties and Responsibilities
<ul>
<li>Provide indirect oversight of cGMP operations at BSM</li>
<li>Work collaboratively within BSM’s Quality Management System</li>
<li>Author, review and approve documentation required to comply with FDA regulations, EU regulations and other regulatory agencies as applicable</li>
<li>Author, review and approve change controls, deviations, CAPAs, work orders, and other GMP documents (will be the primary owner of the systems)</li>
<li>Perform/assist in internal audits and regular walkthrough visits to the manufacturing areas and author, review and approves associated reports</li>
<li>Work collaboratively with other departments in order to accomplish project goals</li>
<li>Assist in the execution of the Pest Control program</li>
<li>Well-organized and proficient at reviewing and editing documentation</li>
<li>Ability to maintain attention to detail while executing multiple tasks</li>
<li>Ability to manage timelines to meet department goals</li>
<li>Maintain control and confidentiality of documents and information</li>
<li>Other duties as assigned by Manager</li>
</ul>
Regulatory Responsibilities 
<ul>
<li>Exhibit a quality mindset</li>
<li>Conduct business in a responsible manner that complies with all state, OSHA and Federal regulations</li>
<li>Develop detailed and comprehensive understanding of FDA, EU and other regulatory agency requirements</li>
</ul>
Supervisory Responsibilities
<ul>
<li>N/A </li>
</ul>
Experience
<ul>
<li>One (1) to three (3) years of experience working in a cGMP environment (preferably in a QA function)</li>
</ul>
Education
<ul>
<li>Associate’s Degree (relevant experience may be substituted for degree)</li>
</ul>
Knowledge, Skills &amp; Abilities
<ul>
<li>Skilled in the use of Microsoft office applications (Word, Excel, PowerPoint) and Adobe Acrobat</li>
<li>High attention to detail</li>
<li>Good writing, public speaking and presentation skills</li>
</ul>
Physical Requirements
<ul>
<li>Ability to sit for prolonged periods of time</li>
<li>Ability to lift up to 25lbs</li>
<li>Ability to stand for prolonged periods of time</li>
</ul>

QA Compliance Specialist I

<h3>Job Description</h3>
Job Description
Who We Are: 
At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented and diverse workforce in our industry. Our commitment to uncompromising focus on quality, compliance, safety, and excellence in delivery shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth, and a desire to make a difference.
Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation. 
Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients. 
Role Overview: 
The QA Deviations Associate will oversee the investigation, documentation, oversight, and resolution of deviations to ensure compliance with regulatory standards, internal policies, and industry best practices. The ideal candidate will bring expertise in deviation investigations for CGMP manufacturing and testing, an understanding of chemical processes for intermediates and APIs, a proactive problem-solving mindset, a coaching mindset, and a commitment to maintaining the highest standards of product quality and safety. This role is both a hands-on role and an oversight role for deviations. 
Core Responsibilities: 
<ul>
<li>Provide oversight on open deviation records and ensure owners are progressing and closing on time as defined by site procedures. </li>
<li>Ensure consistent quality of investigation records, root cause investigation, report writing, and CAPA/Effectiveness Check development for deviations in collaboration with cross-functional teams. </li>
<li>Draft, review, and approve deviation reports, ensuring accuracy, completeness, and compliance with Current Good Manufacturing Practices (CGMP) and other applicable regulations (e.g., FDA, EMA). </li>
<li>Develop and implement corrective and preventive actions (CAPAs) to address identified issues and mitigate recurrence. </li>
<li>Provide guidance and training to QA team members and operational staff on deviation management processes. </li>
<li>Lead the Deviation and CAPA board to routinely monitor the status of open deviations and CAPAs. </li>
<li>Maintain and update deviation tracking systems, ensuring timely closure of investigations and documentation. </li>
<li>Collaborate with manufacturing, engineering, and quality control teams to identify trends and recommend process improvements. </li>
<li>Present a review of deviation root cause trends and system metrics for Management Review meetings at the site and corporate level. </li>
<li>Support internal and external audits by preparing deviation-related documentation and participating in audit responses. </li>
<li>Ensure all activities align with company SOPs, regulatory requirements, and quality objectives.</li>
<li>Aid in the harmonization and maintenance of harmonization of the Quality Management Systems for deviations across sites, updating procedures, decision trees and compliance tools for the site, as needed. </li>
<li>Participate in FDA inspections, audits, and inspections or in client audits as needed as an SME for the Quality System for deviations.</li>
<li>Educate staff on best practices, including new hire quality orientation and compliance training.</li>
<li>Other duties as assigned.</li>
</ul>
Qualifications:
Required
<ul>
<li>Bachelor’s degree in a scientific or technical field (e.g., Biology, Chemistry, Engineering) or equivalent experience. </li>
<li>3+ years of experience with deviation management in a regulated industry (pharmaceuticals, biotech, or medical devices preferred). </li>
<li>In-depth knowledge of CGMP, ICH guidelines, and regulatory standards (e.g., 21 CFR Part 11, ISO 13485) governing deviations. </li>
<li>Proven experience leading complex investigations and writing detailed technical reports. </li>
<li>Strong analytical skills and proficiency with root cause analysis tools (e.g., 6M, 5 Whys, Fishbone). </li>
<li>Excellent communication and interpersonal skills, with the ability to work effectively in a team-oriented environment. </li>
<li>Excellent technical writing skills and the ability to clearly express ideas in English.</li>
<li>Proficiency in quality management software (e.g., TrackWise, Veeva, MasterControl).</li>
<li>Able to successfully interface with internal and external customers.</li>
<li>Ability to work independently and in a team environment.</li>
<li>Experience with Microsoft Office applications, including Word, Excel and PowerPoint at a minimum. </li>
</ul>
Preferred
<ul>
<li>Certification as a Deviation Investigator/Reviewer</li>
<li>Experience creating metrics for driving continuous improvement</li>
<li>Experience working in drug substance manufacturing</li>
</ul>
Our Commitment:
<ul>
<li>Health &amp; Wellness: Comprehensive health &amp; Wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies. </li>
</ul>
<ul>
<li>Financial Wellness: Comprehensive total compensation package that includes competitive base salary, Defined Contribution Pension program, eligibility for performance-based bonuses, and attractive 401(k) Plan with company match.</li>
</ul>
<ul>
<li>Professional Development: Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs.</li>
</ul>
<ul>
<li>Inclusive Culture: At Veranova an inclusive culture is integral to our values. We are committed to ensuring that everyone can bring their full self to work and thrive in their career.</li>
</ul>
How to Apply: 
At Veranova, we are on a mission to meet people that believe in our values and can contribute to the team in a variety of ways. Please visit <a href="http://www.veranova.com" target="_blank">www.veranova.com</a> to view all open roles and join our Talent Community to stay connected and learn about opportunities as they arise. 
We value a range of experiences and perspectives. If you want to be part of improving and saving the lives of patients, we encourage you to apply regardless of whether you meet every qualification listed. 
If you are a veteran, first responder, or in the process of transitioning from service member to civilian life, we encourage you to apply. Your experience brings invaluable skills and insights that can contribute to our team.
For applicants who may require a reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email to <a href="mailto:talentacquisition@veranova.com" target="_blank">talentacquisition@veranova.com</a> in order to confirm your request for an accommodation. Please include the job number, title, and location of role. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Veranova employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Additional Information:
Applicants for this role must be authorized to work in the United States without further employer sponsorship.
Agency and Search Firm Representatives: Veranova does not accept unsolicited resumes from agencies and/or search firms for this job posting. 
Important Notice Regarding Recruitment Scams: Veranova is committed to providing a professional and secure recruitment experience for all applicants. Unfortunately, fraudulent job postings and recruitment scams are becoming more prevalent. We want to ensure that all candidates are aware of potential scams. Please see our notice here.
<ul>
<li>Legitimate communications from Veranova will only come from official email addresses using our domain: @veranova.com.</li>
<li>Legitimate LinkedIn communications will only come from active Veranova employees.</li>
<li>Veranova will never ask candidates for sensitive personal information during the application process (e.g., bank account details or social security number).</li>
<li>Veranova will never ask candidates for payment (e.g., for equipment, training, or background checks).</li>
</ul>
If you have any doubts or concerns about the authenticity of a job posting, please reach out to our HR department: <a href="mailto:pharm.hr@veranova.com" target="_blank">pharm.hr@veranova.com</a> (US) or <a href="mailto:UKHR@veranova.com" target="_blank">UKHR@veranova.com</a> (UK).
All your information will be kept confidential according to EEO guidelines.
Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law.
All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice.

Quality Assurance Deviations Associate

<h3>Job Description</h3>
Job DescriptionPosition Title: Quality Assurance Specialist Reports to:&nbsp;Associate Director, Quality Assurance Status: Regular, Full-Time, Exempt Location: Watertown, MA (Onsite) Company Summary:&nbsp;Stratus Therapeutics is a stem cell therapeutic company developing an innovative platform technology for generating self-renewing blood stem cells.&nbsp; We have breakthrough potential to provide patients with rapid and broad access to HLA-compatible transgene-free blood stem cell therapies. Stratus Therapeutics is committed to advancing science and enhancing the health and well-being of patients. This commitment, along with an exciting team culture, drives our efforts to develop an off the shelf stem cell therapeutic platform. Position Summary: We are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our growing team. This role is critical to ensuring the integrity, compliance, and excellence of our cell therapy products through all stages of development and manufacturing. The Quality Assurance (QA) Specialist will play a key role in maintaining our Quality Management System (QMS), supporting GMP activities, and contributing to the advancement of our regenerative medicine pipeline. Specific responsibilities include, but are not limited to:
<ul>
<li>Perform review and approval of GMP documentation including batch records, quality control test data, technical reports to ensure compliance with GMP and regulatory standards</li>
<li>Manage the issuance and/or revision of controlled GMP documentation including production batch records, logbooks, labels and forms ensuring compliance with document control procedures</li>
<li>Maintain a document control system, ensuring that all documents are properly tracked, version-controlled, and readily available to authorized personnel</li>
<li>Conduct quality investigations of non-conformances, deviations, and CAPAs, support root cause analysis and follow-up</li>
<li>Collaborate with Manufacturing, Quality Control, and Process Development teams to ensure that quality is built into all processes</li>
<li>Review and approve SOPs, protocols, validation documents, and change controls</li>
<li>Conduct internal audits and routine QA walkthroughs in GMP manufacturing areas</li>
<li>Support supplier qualification program including material release</li>
<li>Support training and onboarding of personnel on QA and GMP topics</li>
<li>Ensure documentation is maintained accurately and timely in compliance with GDP (Good Documentation Practices) and support the document archival process</li>
<li>Maintain an understanding of regulatory trends and guidelines relevant to advanced therapy medicinal products (ATMPs)</li>
<li>Support audits and inspections by regulatory agencies, clients, and internal stakeholders</li>
</ul>
Qualifications include:
<ul>
<li>Bachelor’s degree in scientific discipline (e.g., Biology, Biochemistry, Biotechnology, Engineering or related field) is required </li>
<li>3+ years of experience in Quality Assurance within a GMP-regulated environment, preferably in cell/gene therapy or biologics industry is required</li>
<li>Strong knowledge of FDA, EMA, and ICH regulations</li>
<li>Excellent attention to detail and organizational skills</li>
<li>Strong verbal and written communication skills</li>
<li>Ability to work in a fast-paced, dynamic environment and collaborate effectively across teams</li>
<li>Must be able to laugh and contribute to a positive work culture</li>
</ul>
 &nbsp;AAP/EEO Statement Stratus Therapeutics is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.&nbsp; We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics. &nbsp;
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