Jobs in Winthrop, MA

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, Sam Altman, John Doerr, Spark Capital, SV Angel Growth, and others.

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

Formation Bio is prioritizing hiring in key hubs, primarily the New York City and Boston metro areas, with additional growth in the Research Triangle (NC) and San Francisco Bay Area. Please only apply if you reside in these locations or are willing to relocate.

The target salary range for this role is: $169,000 - $200,000

Salary ranges are informed by a number of factors including geographic location. The range provided includes base salary only. In addition to base salary, we offer equity, comprehensive benefits, generous perks, hybrid flexibility, and more. If this range doesn't match your expectations, please still apply because we may have something else for you.

You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.