KEY RESPONSIBILITIESServe as the Quality Assurance representative on cross-functional project teamsProvide Quality oversight of domestic and international Contract Manufacturing Organizations (CMOs)Review and approve Master Batch Records and Executed Batch RecordsPerform clinical and commercial batch release and final disposition activitiesReview release testing, stability documentation, and supporting quality recordsPartner with CMC and Manufacturing on technology transfers and process validationReview and approve validation protocols and reportsLead, author, review, and approve investigations, CAPAs, change controls, complaints, and other Quality EventsSupport and improve GMP quality systems, SOPs, policies, and workflowsWork within electronic Quality Management Systems (eQMS)Support Annual Product Reviews, including quality data, metrics, trends, and recommendationsServe as Person-in-the-Plant when requiredCollaborate with Quality, Supply Chain, CMC, Commercial Manufacturing, contract laboratories, and external suppliersQUALIFICATIONSAdvanced knowledge of GMP pharmaceutical manufacturing and product releaseExperience with pharmaceutical dosage forms and/or combination productsHands-on experience with batch record review and final product dispositionExperience managing external CMOs, contract laboratories, and third-party suppliersStrong experience with deviations/investigations, CAPA, change control, complaints, and risk managementValidation and technology-transfer experienceStrong technical writing and quality-event documentation capabilitiesAbility to evaluate complex manufacturing and quality issuesStrong cross-functional and senior-management communication skillsAbility to manage multiple priorities in a fast-paced GMP environmentTalentBurst is recruiting an experienced Senior Manager, GMP Quality for a fully remote pharmaceutical quality leadership opportunity. This role is particularly suited for a senior QA professional with strong experience in GMP manufacturing, batch disposition, external CMO management, quality investigations, CAPA, change control, validation, and commercial product support.
7 days ago