Associate Director GCP Quality Assurance
2 days ago
Associate Director GCP Quality Assurance Base pay range $180,000.00/yr - $210,000.00/yr Associate Director, GCP Quality Assurance Location: SF Bay Area 5 days onsite Overview The Associate Director, GCP QA plays a key role in driving consistency across Quality systems and processes supporting Clinical programs. This role partners closely with GCP QA and Clinical Operations Quality Management to support day-to-day clinical trial activities, including deviations, investigations, audit findings, and CAPA management. The position also contributes to inspection readiness efforts and provides cross-functional guidance on compliance and quality expectations. Key Responsibilities Lead alignment and oversight of Quality Systems across Clinical QA. Assess current processes, identify gaps, implement improvements, and monitor GCP-related Quality Systems. Develop and manage reports tracking key GCP and Clinical Quality metrics. Review and approve deviations and CAPAs. Partner with Regulatory, Clinical Operations, and other stakeholders on compliance issues. Maintain up-to-date knowledge of Health Authority regulations and advise Clinical teams on impacts. Represent Clinical QA in internal presentations and quality initiatives. Identify and escape risks, proposing practical solutions. Contribute to process and system improvement activities. Education & Experience Bachelors degree with ~11+ years of relevant experience, or Masters with ~9+ years, or PhD with ~5+ years, or an equivalent combination of education and experience. Minimum 10 years of experience in pharma/biotech. Strong background in GCP and Quality Systems, including continuous improvement and Quality Risk Management. Deep understanding of clinical trial processes and GCP QA oversight. Ability to analyze complex quality issues and apply risk-based approaches. Experience developing metrics and contributing to quality strategy. Strong collaboration, influencing, and communication skills. Seniority level Director Employment type Full-time Job function Quality Assurance Industries Staffing and Recruiting, Pharmaceutical Manufacturing, and Biotechnology Research #J-18808-Ljbffr
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Associate Director
6 days ago
South San Francisco, United States Septerna Full timeAssociate Director / Director, GCP Quality Assurance Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. The company's Native Complex Platform recapitulates GPCRs with...
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Associate Director
4 weeks ago
South San Francisco, United States Septerna Full timeAssociate Director / Director, GCP Quality AssuranceSepterna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. The company's Native Complex Platform recapitulates GPCRs with...
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Associate Director GCP Quality Assurance
6 days ago
San Francisco, CA, United States Meet Life Sciences Full timeAssociate Director GCP Quality Assurance Base pay range $180,000.00/yr - $210,000.00/yr Associate Director, GCP Quality Assurance Location: SF Bay Area 5 days onsite Overview The Associate Director, GCP QA plays a key role in driving consistency across Quality systems and processes supporting Clinical programs. This role partners closely with GCP QA and...
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Director GCP, Quality Assurance
3 weeks ago
South San Francisco, United States Meet Life Sciences Full timeHead of GCP / Director, GCP Quality Assurance We are a clinical?stage biotechnology company developing first?in?class antibody therapies that target signal regulatory proteins (SIRP) for the treatment of severe immunological diseases and cancer. They are seeking a Head of GCP Director, GCP Quality Assurance to lead our global GCP and play a critical role in...
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Director, GCP Quality Assurance
2 weeks ago
South San Francisco, United States Septerna Full timeSepterna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. The companys Native Complex Platform recapitulates GPCRs with their native structure, function, and dynamics outside...
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Director, GCP Quality Assurance
2 weeks ago
South San Francisco, United States Septerna Full timeSepterna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. The companys Native Complex Platform recapitulates GPCRs with their native structure, function, and dynamics outside...
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Director, GCP Quality Assurance
3 days ago
South San Francisco, CA, United States Septerna Full timeSepterna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. The company's Native Complex Platform™ recapitulates GPCRs with their native structure, function, and dynamics...
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Director, GCP Quality Assurance
5 days ago
South San Francisco, CA, United States Septerna Full timeSepterna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. The company's Native Complex Platform™ recapitulates GPCRs with their native structure, function, and dynamics...
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Associate Director, GVP Quality Assurance
3 weeks ago
San Francisco, United States Cytokinetics Full timeAssociate Director, Clinical Quality Assurance page is loaded## Associate Director, Clinical Quality Assurancelocations: South San Francisco, Californiatime type: Full timeposted on: Posted Yesterdayjob requisition id: R287Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and...
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San Francisco, United States BridgeBio Pharma Full timeAssociate Director/Director, Clinical Quality AssuranceWhen was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a "moneyball for biotech" approach, pooling projects and promising early-stage research from academia together under one...
