Associate Director / Director, GMP Quality

Formation Bio; Town of Boston (NY); Hybrid; USD 161,500 - 202,000; Full time

Benefits offered by this job

Equity

Comprehensive benefits

Hybrid work model

Job summary

Formation Bio in the New York City/Boston area seeks an Associate Director, GMP Quality Assurance to ensure all GMP activities across manufacturing, testing, packaging, labeling, storage, and distribution comply with FDA/EMA/ICH and internal SOPs. The role supports CMC development, audits CDMOs, conducts batch release, and leads investigations.

The ideal candidate is a hands‑on quality leader with strong communication, capable of navigating a fast‑paced biotech environment and exploring

Qualifications

• Bachelor’s degree in a scientific discipline (Chemistry, Biology, Engineering, Pharmaceutical Sciences).
• Minimum of 10 years’ experience in pharmaceutical GMP Quality Assurance, with biologics/large‑molecule manufacturing/testing.
• Strong communication, organization, and collaboration skills.
• Experience with CMO oversight or virtual manufacturing models.
• Ability to lead investigations and write clear, concise supporting documents.

Responsibilities

• Ensure compliance with global regulations (FDA, EMA, ICH) and internal SOPs.
• 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.

Skills

GMP knowledge

Quality assurance

Investigations

Regulatory compliance

Communication

Education

Bachelor's degree in scientific discipline

Job description

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.
• 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.

Qualifications

• Bachelor’s degree in a scientific discipline (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 (FDA, EMA, 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.

Compensation

Total compensation range: $161,500 - $202,000. Individual compensation is determined by role scope, geographic location, and skills & experience. In addition to base salary, equity, comprehensive benefits, and generous perks are offered.

Location

Formation Bio prioritizes hiring in key hubs, primarily the New York City and Boston metro areas, with a hybrid model requiring 3 days per week in office. Applicants from the Research Triangle (NC) and San Francisco Bay Area may also be considered. Please apply only if you reside in these locations or are willing to relocate.

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, 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.