Job Description
Job Description
About Tobin Scientific
Tobin Scientific is a leading provider of cold chain, ambient storage, and transport & logistics services for the biopharma industry. We proudly support a diverse clientele spanning life sciences, academia, government, and more. Recognized for unwavering safety and reliability in the storage and transport of temperature-sensitive products, we excel in serving the complex needs of the pharmaceutical and biotech sectors. Our capabilities extend to laboratory relocation, principal investigator support, and other logistic services. Tobin Scientific's all-encompassing approach and commitment to quality make us an industry innovator, empowering our partners through the complexities of the biopharma industry.
Position Summary
The Manager, Quality Operations is responsible for ensuring compliance with Good Manufacturing Practices (GMP) across warehouse and logistics operations. This role provides quality oversight of daily GMP activities, including product handling, storage, and shipment within temperature-controlled environments. The Manager serves as a key liaison between Quality Assurance and Operations, supporting continuous improvement, maintaining compliance, and ensuring the consistent execution of quality standards across all functions.
Location: Multiple locations, all located north of Boston, MA, including but not limited to Billerica, Wilmington, and Methuen. On-site requirements will be 4 days a week.
Key Responsibilities
- Provide day-to-day Quality oversight for GMP operations, including receipt, storage, labeling, packaging, and distribution of regulated materials.
- Review and approve controlled documentation such as SOPs, work instructions, forms, and batch records.
- Manage and support quality system elements including:
- Deviations: Lead or support investigations, perform root cause analysis, and ensure timely implementation of corrective actions.
- CAPAs: Develop, track, and verify effectiveness of corrective and preventive actions.
- Complaints: Coordinate intake, investigation, trending, and resolution activities.
- Change Controls: Evaluate and approve changes impacting processes, equipment, or documentation.
- Ensure all activities comply with applicable regulations, internal policies, and industry standards (21 CFR Parts 210, 211, etc.).
- Support inspection readiness and participate in external audits.
- Partner cross-functionally with Operations, Facilities, Validation and Facilities teams to ensure consistent implementation of GMP practices.
- Review and approve temperature mapping protocols, qualification reports, and other controlled documents related to cold chain operations.
- Identify opportunities for process improvement and efficiency within Quality Operations workflows.
- Train, mentor, and provide guidance to site personnel on GMP requirements and quality best practices.
- Support the Senior Manager, Quality Operations in site quality initiatives and continuous improvement projects.
Education
- Bachelor's degree in Life Sciences (e.g., Biology, Chemistry, Biochemistry), Engineering, or related technical discipline.
- Advanced degree or relevant professional certification (e.g., ASQ, PDA, ISPE) preferred.
Experience and Qualifications
- 2-3 years of experience in Quality Assurance or Quality Operations roles within a GMP-regulated industry (pharmaceutical, biotechnology, medical device, or related field).
- Working knowledge of GMP, GDP, and quality system requirements, including deviations, CAPAs, complaints, and change control.
- Experience in warehousing or cold chain logistics strongly preferred, including handling of controlled temperature storage environments (-20°ree;C, 2-8°ree;C, and 15-30°ree;C).
- Experience working cross-functionally to resolve issues, drive continuous improvement, and support compliance initiatives.
- Proficient in the use of electronic Quality Management Systems (eQMS) and other digital tools (e.g., Veeva, ZenQMS.).
- Strong written and verbal communication skills with the ability to interpret regulations, author technical documentation, and present information effectively.
- Demonstrated attention to detail, organizational skills, and ability to manage multiple priorities in a fast-paced environment.
Benefits:
- Health
- Vision
- Dental
- Life Insurance: Basic and Supplemental
- Long Term Disability
- 401(K) Match
- Unlimited Vacation
- Weekly Pay
- Referral Program
- 9 Paid Holidays
- Tuition Reimbursement
Pay Range:
The annual salary range for this position is as follows:
$100,000 - $120,000.
Compensation depends on relevant experience and/or education, specific skills, function, geographic location, and other factors as applicable by law.
Tobin Scientific is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We are committed to creating an inclusive environment for all our employees.