Associate Director, GMP QA

Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients. The company is backed by investors across pharma and tech, including a16z, Sequoia, Sanofi, Thrive Capital, John Doerr, Spark Capital, SV Angel Growth, and others. 

You can read more at the following links:

• Our Vision for AI in Pharma
• Our Current Drug Portfolio
• Our Technology & Platform

At Formation Bio, our values are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team and individual plays a key part in our mission to bring new treatments to patients faster and more efficiently.

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 champion 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.

• →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

• Bachelor’s degree in scientific discipline (e.g., Chemistry, Biology, Engineering, Pharmaceutical Sciences)
• 8+ years experience in GMP Quality Assurance within pharmaceutical, biologics, or biotechnology 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