Associate Director, GMP Quality
About the Position
The Associate Director, GMP Quality Assurance is responsible for ensuring that all GMP-regulated activities, including manufacturing, testing, packaging, labeling, storage, and distribution of Formation Bio's portfolio are executed in compliance with regulatory requirements, industry standards, and company procedures. This role supports CMC development activities, audits CDMOs, conducts batch release, and performs investigations. The ideal candidate is a hands-on quality leader with strong communication skills and the ability to pivot in a dynamic environment. Additionally, the role explores opportunities to integrate artificial intelligence (AI) technologies to improve efficiency, compliance, and overall quality assurance practices.
Responsibilities
Ensure compliance with global regulations (e.g., FDA, EMA, ICH) and internal SOPs. Policies and Work Instructions
Review and approve GMP documents, including SOPs, master batch records, specifications, protocols, and reports
Perform QA review of executed batch records, supporting manufacturing documents, and testing results to support timely and compliant batch disposition
Support investigations into deviations, OOS/OOT results, environmental monitoring excursions, and quality events
Conduct internal audits to assess compliance and identify improvement opportunities
Conduct the qualification and periodic assessment of suppliers, CDMOs, laboratories, and service providers
Review and maintain Quality Agreements, ensuring external partners meet GMP expectations
Support preparation for and participation in regulatory inspections and due diligence audits
Apply risk management principles (e.g., FMEA) to guide decision-making
Champion a culture of quality, transparency, and continuous improvement
About You
Bachelor’s degree in scientific discipline (e.g., Chemistry, Biology, Engineering, Pharmaceutical Sciences)
Minimum of 10 years’ experience in pharmaceutical GMP Quality Assurance, with specific experience in biologics / large-molecule manufacturing and testing
Deep understanding of GMP expectations (e.g., FDA, EMA, and ICH) and a commitment to patient safety
Excellent communication, organization, and collaboration skills
Ensures accuracy and completeness in documentation and decision-making
Ability to lead investigations and write clear, concise supporting documents
Experience with CMO oversight or virtual manufacturing models
Thrive in a dynamic, fast-paced environment with evolving priorities
Total Compensation Range: $161,500 - $202,000