Associate Director, GMP Quality

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 . Equal Opportunity Formation Bio is committed to building a diverse and inclusive team. We are an equal opportunity employer and welcome candidates from all backgrounds. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, and related medical conditions), gender identity or expression, sexual orientation, age, disability, genetic information, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law.

A meeting lands on your calendar

If they’re a yes, I book the chat. You show up — that’s the whole job-hunt.