Quality Assurance Manager (UK/EU) en Vericel Corporation

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 Quality Assurance Manager – UK & EU will play a pivotal role in building and maintaining Quality Systems to support the commercial launch and ongoing operations of MACI®. The individual will ensure that all products, systems, and activities comply with UK and EU regulatory requirements, including MHRA, EMA, EU/UK MDR, UKCA, GMP/GDP, ATMP, and ISO 13485 standards. This role will act as the regional quality lead, working closely with global QA, regulatory, operations, and external partners.

Position Scope:

• Quality Systems & Compliance
  • Establish, implement, and manage a local QMS aligned with corporate policies and applicable international standards (ISO 13485, EU MDR, UK MDD/MDR, UKCA).
  • Ensure ongoing compliance with regulatory requirements, including MHRA, EMA, EU-GMP/GDP, and ATMP frameworks.
  • Lead internal audits and support external regulatory inspections and Notified Body assessments.
  • Provide oversight of SoHO regulation implementation.
  • Monitor evolving regulatory landscapes in the UK and EU and implement necessary changes.
• Operational & Product Quality
  • Oversee QA activities across the UK/EU supply chain, including cold chain logistics, local labeling, packaging materials, and release for warehousing/distribution, including medical devices accessories and biopsy kits.
  • Manage final product release activities, including batch record review, deviation investigations, and product disposition.
  • Coordinate change controls, CAPAs, and complaint handling related to regional operations.
  • Provide quality oversight of third-party logistics providers, CMOs, and other external vendors.
  • Serve as the designated “Qualified Person” (QP) for all products coming into the country.
  • Ensure proper tracking and compliance of patient biopsies and blood testing.
  • Execute Quality Release per applicable market requirements.
• Regulatory & Cross-Functional Collaboration
  • Act as the primary UK/EU QA point of contact for MHRA and other regulatory bodies.
  • Liaise with global QA and regulatory affairs teams to ensure alignment and support for regional operations.
  • Contribute to inspection readiness, QMS registration, post-market surveillance, and adverse event reporting.
  • Participate in cross-functional initiatives related to product launch, market entry, and supply chain setup.
• Leadership & Quality Culture
  • Build and lead a local quality team as needed to support commercial scale-up.
  • Foster a culture of compliance, continuous improvement, and operational excellence across regional functions.
  • Deliver training, guidance, and mentorship to local team members and stakeholders.

Qualifications:

• Bachelor's degree in Life Sciences, Engineering, Pharmacy, or related field.
• Minimum 10 years of QA experience in medical devices, pharmaceuticals, biologics, or cell and gene therapy industries.
• Strong knowledge of EU/UK GMP, GDP, ISO 13485, EU MDR, UK MDD/MDR, UKCA, and ATMP regulations.
• Experience managing audits, regulatory inspections, supplier qualifications, and product release.
• Demonstrated ability to work cross-functionally in a global, matrixed organization.
• Excellent written and verbal communication skills.
• Willingness to travel within the UK, EU, and occasionally to the U.S.
• QP certification in target geographies (UK/EU).

Preferred Qualifications:

• Advanced degree (MSc, PhD, MBA) is a plus.
• Experience launching a regulated product in new international markets.
• Background in aseptic manufacturing, combination products, or tissue-engineered therapies.
• Familiarity with UK importation, Qualified Person (QP) processes, and interactions with MHRA/EMA.
• Fluency in English, German and/or Dutch.
• Certified ISO 13485 Lead Auditor.

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.