Associate Director / Director, GMP Quality

The role

The Associate Director or Director, GMP Quality ensures GMP-regulated activities for the company portfolio comply with regulatory requirements and industry standards. This role supports CMC development, audits CDMOs, conducts batch release, and performs investigations while exploring AI integration for quality assurance.

What you will do

• Ensure compliance with global regulations and internal SOPs
• Review and approve GMP documents including SOPs, master batch records, specifications, protocols, and reports
• Perform QA review of executed batch records, manufacturing documents, and testing results
• Support investigations into deviations, OOS/OOT results, environmental monitoring excursions, and quality events
• Conduct internal audits to assess compliance and identify improvement opportunities
• Conduct qualification and periodic assessment of suppliers, CDMOs, laboratories, and service providers
• Review and maintain Quality Agreements
• Support preparation for and participation in regulatory inspections and due diligence audits
• Apply risk management principles to guide decision-making
• Champion a culture of quality, transparency, and continuous improvement

Required qualifications

• Bachelor’s degree in scientific discipline (e.g., Chemistry, Biology, Engineering, Pharmaceutical Sciences)
• Minimum of 10 years’ experience in pharmaceutical GMP Quality Assurance
• Specific experience in biologics / large-molecule manufacturing and testing
• Deep understanding of GMP expectations (e.g., FDA, EMA, and ICH)
• Excellent communication, organization, and collaboration skills
• Ability to lead investigations and write clear, concise supporting documents
• Experience with CMO oversight or virtual manufacturing models
• Ability to thrive in a dynamic, fast-paced environment with evolving priorities

Benefits

• equity
• comprehensive benefits
• generous perks

Before you apply

• Please apply only if you reside in New York City, Boston metro areas, Research Triangle (NC), or San Francisco Bay Area or are willing to relocate

About the company

Formation Bio is a tech and AI driven pharma company that has built technology platforms, processes, and capabilities to accelerate drug development and clinical trials. The company partners, acquires, or in-licenses drugs to develop programs past clinical proof of concept and beyond.