Formation Bio · 19 hours ago
Senior Manager, GMP QA
New York, NY
Full-time
Hybrid
Senior Level, Lead/Staff
$169K/yr - $200K/yr
10+ years expFormation Bio is a tech and AI driven pharma company focused on accelerating drug development. The Sr. Manager, GMP Quality Assurance is responsible for ensuring compliance with GMP regulations and overseeing quality assurance practices within the company's portfolio.
Artificial Intelligence (AI)BiotechnologyClinical TrialsHealth CareMedicalPharmaceutical
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
Qualification
Required
Bachelor's degree in scientific discipline (e.g., Chemistry, Biology, Engineering, Pharmaceutical Sciences)
Minimum of 10 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
Benefits
Equity
Comprehensive benefits
Generous perks
Hybrid flexibility
Company
Formation Bio
Formation Bio is a drug development company that strives to provide treatments to patients faster by reimagining clinical trials.
51-200 employees
H1B Sponsorship
Formation Bio has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
Funding
Current Stage
Late StageTotal Funding
$528MKey Investors
Andreessen Horowitz
2024-06-26Series D· $372M
2021-09-30Series C· $156M
2018-10-15Series Unknown
Leadership Team
Benjamine Liu
CEO and Co-founder at Formation Bio
Linhao Zhang
Co-Founder
Recent News
Spark Capital
2026-01-07
BioWorld Financial Watch
2025-12-19
2025-12-16
Company data provided by crunchbase