Associate Director, GMP Quality
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
- 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, 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
- Thrives in a dynamic, fast-paced environment with evolving priorities
Qualifications
- Hands-on quality leadership experience
- Strong communication and collaboration skills
- Experience with AI technologies to improve quality assurance practices
Skills
- Compliance with GMP regulations
- Quality assurance and investigation skills
- Internal audit and supplier qualification experience
- Regulatory inspection and due diligence audit support
- Risk management principles
- Leadership and mentoring skills
Benefits
Total Compensation Range: $122,000 - $152,500
Individual compensation is determined by several factors, including role scope, geographic location, and skills & experience.
In addition to base salary, we offer equity, comprehensive benefits, and generous perks.
If the posted range doesn't match your expectations, we still encourage you to apply!
Where We Hire: Formation Bio is prioritizing 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.
Pay
Total Compensation Range: $122,000 - $152,500
Individual compensation is determined by several factors, including role scope, geographic location, and skills & experience.
In addition to base salary, we offer equity, comprehensive benefits, and generous perks.
If the posted range doesn't match your expectations, we still encourage you to apply!
Schedule
Formation Bio is prioritizing 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.