Associate Director, GMP Quality

Formation Bio is seeking an Associate Director, GMP Quality Assurance to ensure that all GMP-regulated activities are executed in compliance with regulatory requirements, industry standards, and company procedures.

The ideal candidate is a hands-on quality leader with strong communication skills and the ability to pivot in a dynamic environment. 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

Requirements:

• 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