Meet Life Sciences
Associate Director GCP Quality Assurance
Meet Life Sciences, San Francisco, California, United States, 94199
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
Bachelor’s degree with ~11+ years of relevant experience,
or Master’s 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
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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
Bachelor’s degree with ~11+ years of relevant experience,
or Master’s 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