Director of Quality

Our client is seeking an experienced Director of Quality to lead and develop their Quality function at their Boston-based site.

This is a key leadership position responsible for ensuring end-to-end GxP compliance across clinical and commercial-stage programs. The successful candidate will play a critical role in maintaining regulatory standards, driving quality strategy, and supporting the organisation through inspection readiness and continued growth.

Key Responsibilities

• Lead and oversee Quality Assurance and Quality Control activities
• Own and enhance the Quality Management System (QMS)
• Ensure compliance with GMP, GCP, and/or GLP regulations
• Act as the primary Quality representative for regulatory interactions
• Oversee CDMO and vendor quality management
• Drive deviations, CAPAs, change controls, and risk management
• Partner cross-functionally with CMC, Manufacturing, Clinical, and Regulatory teams
• Build and develop a high-performing Quality team
• Support clinical to commercial transition activities where applicable

Requirements

• Bachelor’s degree in Life Sciences (advanced degree preferred)
• 10–15+ years’ experience in Quality within pharma/biotech
• Proven leadership experience at Senior Manager / Director level
• Strong knowledge of FDA, EMA, ICH and global GxP regulations
• Demonstrated experience leading regulatory inspections
• Experience managing external vendors / CDMOs

Preferred Experience

• Biologics, cell & gene therapy, or RNA therapeutics
• Building or scaling Quality systems in emerging companies
• Supporting IND, NDA, or BLA submissions