Head of Quality Assurance

Location: Remote with travel to the Boston area as needed

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​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 pediatric disease, with promise to impact many other diseases. This global team is seeking a Head of Quality Assurance to take ownership and lead the Quality Assurance function and work with cross functional leaders to support production and disposition of clinical cell therapy batches. The successful candidate will thrive in an early-stage clinical biotech start-up 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 procedures 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

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Required qualifications:

• Bachelor’s degree in life science or engineering discipline, higher degree preferred

• 8+ 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

Other:

This is a full-time, 40 hour per week permanent leadership position based in an office setting with 5% travel requirement to external partner organizations. Due to the current COVID-19 crisis, our client has agreed to complete the interview and onboarding process for this position remotely. The successful candidate will perform the duties of this position remotely until it becomes safe to travel, at which time this position will be a fully office-based position.

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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.

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Compensation: Competitive base salary and industry leading benefits package