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Title: Manager/Senior Manager, Quality AssuranceReports To: Associate Director, Quality Assurance Operations Location: Redwood City, California Classification: Exempt Overview:The Manager/Senior Manager, Quality Assurance, represents the quality organization at Coherus and at Contract Manufacturing Organizations (CMOs) to ensure appropriate oversight/monitoring of production, and ensure continuous supply of clinical and commercial products.
$170,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Desired QualificationsProven experience (5+ years) in quality assurance, ideally within clinical-stage manufacturing for a biotech company. Participate in tech transfer from clinical production to commercial production within the next 1-2 years.
Full-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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Annexon Biosciences seeks a Quality Assurance (QA) Director/Senior Director to lead the company’s clinical Quality Assurance (cQA) program. Provide Clinical Quality Assurance (GCP) strategic and technical leadership and Subject Matter Expertise (SME) to clinical study teams; Partner with the teams to effect appropriate and timely documentation of quality event management, including CAPA plans in support of the Annexon product pipeline.
$275,000 a yearFull-timeExpandApply NowActive JobUpdated 17 days ago - UpvoteDownvoteShare Job
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The Manager of Clinical Quality Assurance (CQA) is a key member of the CQA team and will perform day-to-day clinical quality operations and compliance activities to support the success of the clinical studies sponsored or supported by Corcept.
$170,300 a yearFull-timeExpandApply NowActive JobUpdated 17 days ago - UpvoteDownvoteShare Job
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Founded in 2015 at the birthplace of biotechnology, Nkarta is a fast-growing, fast-moving, clinical-stage company that has built an extensive cell therapy manufacturing operation in anticipation of product commercialization.
Full-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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Work closely with GxP Quality Assurance and functional areas responsible for the conduct of clinical research (e.g., Clinical Operations, Clinical Development, Biostatistics and Data Management, Pharmacovigilance, etc.
$230,000 a yearFull-timeRemoteExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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The candidate will be reporting to VP of Quality Assurance and is responsible for the strategic development and management of QA operations to support CMC operations and clinical activities in compliance with FDA, ICH, EMA regulations, guidances, industry standards, and company policies.
$260,000 a yearFull-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Ensures that personnel, methods, corporate policies and standard operating procedures comply with: FDA requirements for Good Laboratory Practices (GLP) for conducting scientific research, current Good Manufacturing Practice (cGMP), Quality System Regulation (QSR), Good Clinical Practices (GCP), and 21 CFR Part 11.
Full-timeExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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As the Associate Director, Clinical Quality Assurance (CQA), you are a key member of the Clinical Quality team maintaining representing Clinical QA in cross functional setting, and advising Cytokinetics Clinical Operations, Biometrics, Drug Safety and Pharmacovigilance teams on GCP matters.
$226,000 a yearFull-timeExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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By unlocking the information present in microbial cell-free DNA, we're helping doctors quickly solve their most challenging cases, providing industry partners with access to the microbial landscape to accelerate biomarker discovery and clinical trials, discover novel microbes, to ultimately reduce patient suffering worldwide.
Full-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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Review manufacturing, packaging, and labeling Drug Product batch records and in-process quality control data and assess the completeness of change controls, deviations, and test results to ensure timely disposition of drug products intended for commercial or clinical use.
Full-timeExpandApply NowActive JobUpdated 25 days ago - UpvoteDownvoteShare Job
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Thorough knowledge of standards, systems, policies and procedures that enable Good Clinical Practices (GCP), QMS operations and compliance within the biopharma industry. You will act as the R&D Quality Business Partner to assigned groups, such as Gilead R&D functions or vendors supporting Gilead R&D. You will provide strategic, expert advice and consultation on R&D quality, risk and continuous improvement with impact across cross-functional Good Clinical Practices (GCP.
$100 an hourExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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The ideal candidate will have extensive experience leading GMP quality assurance activities and deep understanding and demonstrated working knowledge of CFRs, ICH guidance documents, and other regulations that govern GMP compliance during clinical development and commercialization of small molecule drug product.
$308,000 a yearFull-timeExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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The Quality Assurance and Document Control Manager will be responsible for overseeing all quality assurance activities and document control processes to support CAR T GMP manufacturing and IND/Clinical phases.
Full-timeExpandApply NowActive JobUpdated 27 days ago - UpvoteDownvoteShare Job
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Demonstrated in-depth experience of establishing, refining, and operating Quality Assurance related systems for clinical manufacturing in the Biotechnology industry. In depth knowledge of regulations and guidance supporting phase appropriate cGMP to include FDA, EMA, ISO standards and ICH guidelines with direct impact to clinical programs.
$180,000 a yearFull-timeExpandApply NowActive JobUpdated 23 days ago
clinical job Title: assurance in San Mateo, CA
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