Senior Manager, GMP QA

Formation Bio(1 month ago)

HybridFull TimeManager$169,000 - $200,000Quality Assurance

About this role

The Senior Manager, GMP Quality Assurance at Formation Bio is a leadership role focused on upholding product quality and regulatory integrity across the company's clinical and manufacturing portfolio. The position partners with internal and external stakeholders to advance quality systems, support development activities, and drive continuous improvement. It also evaluates opportunities to apply AI to enhance QA efficiency and practices. This is a hands-on role in a fast-paced, growth-oriented biotech environment.

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Required Skills

GMP Compliance
Document Review
Batch Release
Investigations
Internal Audits
Supplier Qualification
Quality Agreements
Regulatory Inspections
Risk Management
Quality Leadership

+2 more

Qualifications

Bachelor's Degree in Scientific Discipline

About Formation Bio

formation.bio

Formation Bio is a next‑generation pharmaceutical company focused on "building the pharma company of the future." They use a platform-driven approach that combines automated, data‑centric discovery and engineering with integrated development capabilities to accelerate the translation of novel therapeutics. Operating an end‑to‑end model, Formation aims to shorten timelines and lower costs by tightly coupling discovery, preclinical development, and commercialization. They work with partners across academia, investors, and industry to advance and scale promising drug programs.