Director, Quality Assurance

George Higginson is currently searching for a Director of Quality Assurance with experience in sterile manufacturing / aseptic operations for a start-of-the-art CDMO client based in New Jersey.

This opportunity is with a growing small-to-mid-sized CDMO operating from a 60,000 sq. ft. state-of-the-art GMP manufacturing facility
, supporting complex pharmaceutical development and manufacturing programs.

The team is looking for a hands-on Director of QA to lead Quality activities across the site, taking ownership of site Quality strategy, compliance and inspection readiness while managing a small, high-performing team. This role would suit someone who enjoys balancing leadership responsibilities with day-to-day Quality involvement rather than operating purely at an executive level.

A major focus for this position is experience within sterile manufacturing / aseptic operations
, alongside confidence representing Quality in front of both clients and regulatory agencies.

• Lead site-wide Quality Assurance activities across GMP operations
• Manage and mentor a small QA team (approximately 4–5 people)
• Act as the site Quality lead for client interactions and Quality discussion
• Drive inspection readiness and represent Quality during regulatory inspections
  
  Support and oversee deviations, CAPAs, change controls and Quality systems activities
• Partner closely with Manufacturing, Technical Operations and broader leadership teams
• Ensure ongoing compliance with FDA, DEA, State DOH and other regulatory requirements
• Maintain and strengthen Quality culture across the site

• Extensive Quality Assurance experience within pharmaceutical manufacturing environments
• Strong background within sterile fill-finish / aseptic manufacturing
• Previous experience leading Quality teams and site-level Quality activities
• Hands-on QA expertise rather than purely strategic or corporate oversight experience
• Experience leading or supporting client audits and regulatory inspections
• Strong understanding of cGMP regulations and Quality systems
• Ability to operate effectively within a growing, highly collaborative CDMO environment

If this sounds like something you’d be interested in discussing, feel free to reach out directly or apply below.