Senior Manager, GMP Quality Assurance

Position Summary The Senior Manager, Quality Assurance – Drug Product is responsible for providing quality oversight of outsourced drug product (DP) manufacturing, packaging, labeling, testing, release, and distribution activities across clinical‑stage and late‑phase development programs. Primary QA representative for DP contract manufacturing organizations (CDMOs) and testing laboratories, ensuring GMP compliance and inspection readiness throughout the product lifecycle. Primary Quality point of contact for Qualified Persons (QPs) supporting EU batch certification and release activities. Job Responsibilities Serve as QA lead for drug product CDMO oversight, ensuring GMP compliance across manufacturing, testing, packaging, labeling and release. Provide real‑time QA support for DP manufacturing campaigns (batch disposition, deviation management, laboratory investigations, change control). Review and approve key GMP documents (master batch records, executed batch records, protocols, reports, specifications). Oversee timely resolution of deviations, investigations, CAPAs, and change controls. Act as primary QA interface with CDMOs. Participate in vendor selection, qualification, and ongoing performance management (audits, quality agreements). Collaborate cross‑functionally with Analytical Development, QC, Manufacturing, Regulatory Affairs, and Supply Chain. Support regulatory inspections and filings. Contribute to continuous improvement of external manufacturing quality systems and procedures. Mentor QA team members. Support risk management for quality and supply risks. Participate in internal audits and health authority inspections as drug product quality SME. Provide QA support to early‑phase programs as needed; support blinded/unblinded clinical supply operations (labeling/packaging controls). Stay current with evolving GMP/ICH regulatory requirements. Qualifications Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field. 8+ years in pharma/biotech with significant Quality Assurance experience. Strong knowledge of FDA, EMA, MHRA, ICH, and global GMP regulations. Experience with batch disposition and release for clinical products. Proven oversight of CDMOs/external manufacturing networks. Working knowledge of EU Qualified Person (QP) certification and batch release requirements. Experience with batch disposition, deviations/lab investigations, change control, CAPA, and risk management. Blinded/randomized/placebo‑controlled clinical study experience preferred. Strong cross‑functional collaboration; ability to influence without authority. Excellent communication, problem‑solving, organizational skills; demonstrated leadership/mentoring. Ability to manage multiple priorities in a fast‑paced environment. Travel Required Up to ~20–30% travel. Benefits Annual performance incentive bonus; new hire equity; ongoing performance‑based equity; medical/dental/vision, 401k match, unlimited PTO, paid holidays including winter shutdown. Application Instructions Apply via the official career page at BambooHR. #J-18808-Ljbffr Scorpion Therapeutics