Sr. Manager Quality

Role: Senior Quality leader responsible for establishing and maintaining Absci's Quality Management System across GxP environments (GCP, GMP, GLP) to support clinical-stage biotech operations. Responsibilities include developing SOPs, managing audits (internal and vendor), ensuring regulatory compliance, overseeing CAPA and change control, and partnering cross-functionally with R&D, clinical, manufacturing, IT, and legal teams to embed quality early in workflows. Requirements: 8+ years in biotech or pharma quality, hands-on experience with GCP/GMP/GLP, proven QMS ownership, and direct involvement in FDA/EMA inspections. Bachelor's in life sciences or related field; advanced degree preferred. High-Value: experience supporting clinical-stage biotech, with exposure to cell line development or biologics manufacturing; familiarity with Veeva QMS, AI/ML quality considerations, and computer system validation; strong risk-based approach and strategic/operational versatility. WorkSetup: senior individual contributor with growth potential, based in the U.S., with some travel expected.