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