Director, Enterprise Applications and IT Compliance

Vericel Corporation

Burlington, MA, USA

Published: 6/14/2022

Technology

Full Time

Job Description

At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care). 

Position Summary:

The Director of Enterprise Applications and IT Compliance will own and lead the management, strategy, and oversight of critical enterprise applications and their respective teams, including Manufacturing Execution Systems (MES), Laboratory Information Systems (LIS), Quality Management Systems (QMS), and Enterprise Resource Planning (ERP)/Customer Relationship Management (CRM) platforms. This role ensures that IT systems supporting GxP, SOX, and other regulatory frameworks operate efficiently, securely, and in full compliance with industry and company standards.

This leader will manage a team who serve as system managers for these platforms and will also oversee the IT compliance vendor, which provides both operational support for Computerized System Assurance (CSA) and Computerized System Validation (CSV) activities and strategic compliance advisory services.

Schedule:

This position is in-office from Monday – Thursday in our new Burlington, MA location, with flexibility to work remotely on Fridays. 

Position Scope:

Enterprise Applications Leadership

Lead the overall strategy, governance, and roadmap for MES, LIS, QMS, and ERP/CRM platforms.
Manage and guide system managers responsible for these applications, ensuring optimal system performance, integration, and lifecycle management.
Partner with business leaders across company to ensure enterprise applications align with business objectives and needs.
Collaborate with IT Infrastructure and Security teams to maintain high availability, scalability, and security of enterprise applications.
Ensure effective vendor management for SaaS, cloud-hosted, and on-premises applications.

IT Compliance & Quality Management

Oversee IT compliance activities, ensuring adherence to CSA, CSV, 21 CFR Part 11, GAMP 5, GxP, and SOX requirements, etc.
Manage and guide the IT compliance vendor in executing validation, qualification, and risk-based testing strategies.
Accountable for, IT compliance-related records in the QMS system, including, Change Control Records (CCRs), Events and Deviations, Subject Matter Expert (SME) assessments and other IT-related quality documentation
Act as an IT representative in audits and regulatory inspections, ensuring documentation and processes meet compliance standards.

Strategic IT Governance & Risk Management

Define and implement governance frameworks for enterprise applications, with a particular focus on compliance, security, and operational efficiency.
Ensure alignment with internal IT controls, SOX compliance, and cybersecurity policies.
Develop and maintain policies and SOPs for IT compliance, application management, and system lifecycle management.
Drive IT risk management processes, including vendor risk assessments and security reviews for regulated applications.

Team Leadership & Cross-Functional Collaboration

Direct and develop a team of system managers overseeing critical enterprise applications.
Foster a culture of continuous improvement, accountability, and compliance awareness within IT and across business teams.
Partner with Quality, Manufacturing, Commercial, Regulatory, Clinical and Finance leaders to optimize enterprise applications and compliance processes.
Stay current with regulatory changes, emerging IT compliance trends, and best practices in life sciences IT.

Qualifications:

10+ years of IT experience in the life sciences industry, with proven expertise in enterprise application management and IT compliance.
Proven leadership experience in managing enterprise systems such as MES, LIS, QMS, and ERP/CRM etc.
Strong understanding of CSA/CSV principles and compliance with GxP, 21 CFR Part 11, GAMP 5, and SOX regulations.
Vendor management experience, including oversight of IT compliance service providers.
Excellent knowledge of IT governance, risk management, and lifecycle management of enterprise applications.
Ability to effectively communicate complex IT compliance requirements to business and IT stakeholders.

Preferred Qualifications

Familiarity with life sciences manufacturing, supply chain, commercial, and quality processes.
Hands-on experience with both on-prem and cloud-based enterprise applications in a regulated environment.
Experience supporting regulatory audits and inspections.
Certification in ITIL, PMP, or a related IT governance framework.
Strong project management and communication skills
Proven ability to manage time effectively and handle multiple conflicting priorities.

Why Vericel?

Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care.
Career Growth: Be a part of a growing organization with opportunities to expand your impact.
Collaborative Culture: Work alongside a team of dedicated professionals who are passionate about improving lives.

EEO Statement

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.