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: $122,000 - $152,500
Compensation Individual compensation is determined by several factors, including role scope, geographic location, and skills & experience. Your offer will reflect where you fall within the range based on these considerations. In addition to base salary, we offer equity, comprehensive benefits, and generous perks. If the posted range doesn't match your expectations, we still encourage you to apply!
Where We Hire Formation Bio is prioritizing hiring in key hubs, primarily the New York City and Boston metro areas, with a hybrid model requiring 3 days per week in office. Applicants from the Research Triangle (NC) and San Francisco Bay Area may also be considered. Please apply only if you reside in these locations or are willing to relocate
