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About the Role

The Associate Director, GMP Quality Assurance is responsible for ensuring all GMP-regulated activities comply with regulatory requirements, industry standards, and company procedures. This role supports CMC development, 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 adapt in a dynamic environment. The role also explores integrating AI to improve 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
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

Skills

AI technologies
Risk management principles (e.g., FMEA)
Communication skills
Organization skills
Collaboration skills

Location

New York City metro area
Boston metro area
Research Triangle (NC)
San Francisco Bay Area

Work Type

Hybrid

Experience Level

Associate Director
Minimum of 10 years’ experience

Education Level

Bachelor’s degree in scientific discipline

Salary/Compensations

$122,000 - $152,500

Benefits

Equity
Comprehensive benefits
Generous perks

About the Company

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.
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.
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.

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.