Vice President, Head of Quality

Location United States of America
Discipline: Regulatory Affairs
Job type: Permanent
Salary: £Compensation: competitive base salary and benefits package (details upon interview)
Contact name: Caroline Webster

Contact email:
Contact phone: 16179821238
Job ref: CW-VP-HQ-130521
Published: about 1 month ago
Expiry date: 13 June 2021

Type: Full-time permanent

The opportunity

We have partnered with an exciting, clinical-stage biotech company dedicated to a bold mission to develop treatments for rare diseases. Our client's unique technology platform is currently in clinical trials to treat a devastating rare diseases, with promise to impact many other therapeutic areas. This global team is seeking a VP/Head of Quality Assurance to take ownership in building and leading the Quality Assurance and Quality Control functions and work with cross functional leaders to support production and disposition of clinical product. The successful candidate will thrive in an early-stage clinical biotech environment and be an excellent team player with the ability to wear many hats as needed. Core responsibilities in the position of Head of Quality Assurance include:

  • Direct, lead and oversee the entire Quality Assurance function within a growing US and global team environment

  • Lead batch record review and lot disposition

  • Conduct all vendor audits, manage and documentation and vendor qualification

  • Write, revise and review all controlled Quality documents

  • Collaborate with process development, Regulatory, CMC and Head of Manufacturing to perform tech transfer of new processes into GMP manufacturing environment

  • Lead the development of Quality Systems and applicable proceedures to ensure the highest standard of compliance with GxP

  • Review and maintain all Quality Agreements

  • Manage tracking of all investigations, OOS, and CAPAs

  • Train, manage and oversee team members as required while promoting and educating on best Quality Assurance principles

Required qualifications:

  • Bachelor's degree in life science or engineering discipline, advanced degree preferred

  • 12+ years' experience in positions of progressive leadership within Quality Assurance

  • Hands on experience conducting and reviewing clinical batch records and product lot disposition

  • Extensive knowledge of GMP regulations within the US and globally (FDA, EMEA)

  • Previous experience in Quality Assurance with biologics, cell or gene therapy products preferred

  • Ability to develop, implement and manage Quality Systems

  • Strong organizational and cross functional communication skills

Our client is deeply committed to workplace diversity and inclusion and is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.

Compensation: competitive base salary and benefits package (details upon interview)