Associate Director, GMP Quality

About Formation Bio

Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development.  

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.

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 Compensatio …