{"schemaVersion":"jobsearcher.job.v1","id":"bdcead8d81b802b199c3ee44","url":"https://jobsearcher.com/jobs/bdcead8d81b802b199c3ee44","canonicalUrl":"https://jobsearcher.com/jobs/bdcead8d81b802b199c3ee44","title":"Manager, GMP Quality","description":"Manager, GMP Quality\nKey Responsibilities\nProvide QA oversight of all Quality Control activities, including test method validations, product specifications, and stability programs\nCollaborate with internal and external stakeholders on deviation investigations, OOX investigations, CAPA plans, change controls, shelf-life extensions, and documentation revisions\nPartner with PDM/CMC, Supply Chain, Analytical Development, and other functions to support day-to-day GMP QA operations\nServe as Quality SME for the execution of Quality Systems including Deviations, CAPAs, Change Controls, and related processes\nIn partnership with Analytical Development, provide quality oversight and approval of method validations, specifications, release testing, and stability programs for Drug Substance and Drug Product\nReview and approve CMO documentation (specification documents, master batch records, label proofs, executed batch records, in-process and release test data) and perform product dispositions\nQualifications\nBachelor’s degree in a scientific or technical discipline required\nMinimum 5 years of GMP Quality experience in the pharmaceutical industry; late-stage drug product development and validation experience preferred\nStrong technical background in small molecule process development, validation, and testing\nKnowledge of applicable US and global GMP regulations and industry standards\nAbility to evaluate and troubleshoot complex technical problems independently\nStrong cross-functional collaboration and communication skills; ability to manage multiple priorities under aggressive timelines","company":"Simulstat","rawCompany":"simulstat","city":"Remote","state":"OR","isRemote":false,"isActive":false,"createdAt":"2026-08-03T14:50:28.664Z","occupations":[{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"11-9121.00","title":"Natural Sciences Managers","slug":"natural-sciences-managers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Manager, GMP Quality","description":"Manager, GMP Quality\nKey Responsibilities\nProvide QA oversight of all Quality Control activities, including test method validations, product specifications, and stability programs\nCollaborate with internal and external stakeholders on deviation investigations, OOX investigations, CAPA plans, change controls, shelf-life extensions, and documentation revisions\nPartner with PDM/CMC, Supply Chain, Analytical Development, and other functions to support day-to-day GMP QA operations\nServe as Quality SME for the execution of Quality Systems including Deviations, CAPAs, Change Controls, and related processes\nIn partnership with Analytical Development, provide quality oversight and approval of method validations, specifications, release testing, and stability programs for Drug Substance and Drug Product\nReview and approve CMO documentation (specification documents, master batch records, label proofs, executed batch records, in-process and release test data) and perform product dispositions\nQualifications\nBachelor’s degree in a scientific or technical discipline required\nMinimum 5 years of GMP Quality experience in the pharmaceutical industry; late-stage drug product development and validation experience preferred\nStrong technical background in small molecule process development, validation, and testing\nKnowledge of applicable US and global GMP regulations and industry standards\nAbility to evaluate and troubleshoot complex technical problems independently\nStrong cross-functional collaboration and communication skills; ability to manage multiple priorities under aggressive timelines","datePosted":"2026-08-03T14:50:28.664Z","dateModified":"2026-08-03T14:50:28.664Z","hiringOrganization":{"@type":"Organization","name":"Simulstat","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Remote","addressRegion":"OR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"bdcead8d81b802b199c3ee44"},"url":"https://jobsearcher.com/jobs/bdcead8d81b802b199c3ee44"}}