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Job description
Key Accountabilities / Core Job Responsibilities:
Lead the GCP deviation and CAPA processes, ensuring timely investigation, implementation, effectiveness verification, and closure.
Partner with study teams to identify, assess, and mitigate quality risks across clinical development programs using Quality by Design (QbD) and risk-based quality management principles.
Serve as the subject matter expert on GCP quality risk management, guiding detection, investigation, documentation, and resolution of GCP noncompliance.
Maintain quality oversight of the Clinical Trial Risk Tracking Program, ensuring risks are documented, monitored, and escalated.
Analyze quality and compliance data, identify trends, develop meaningful metrics, and communicate insights to leadership and cross-functional stakeholders.
Review deviations, noncompliance, and quality events to identify systemic risks and drive continuous improvement.
Lead GCP and GVP vendor qualification and ongoing quality oversight to ensure regulatory and company compliance.
Support regulatory inspections and audits with inspection readiness, documentation review, response development, and follow-up.
Enhance the Quality Management System (QMS) by improving quality risk management processes, tools, and best practices.
Qualifications / Skills:
Bachelor’s with 12+ years GCP Quality Assurance experience; or Master’s with 10+ years; or PhD with 7+ years; or equivalent education/experience.
Expertise in ICH E6 GCP, GVP, FDA regulations, and applicable global requirements.
Experience with QbD, RBQM, and QMS principles in clinical development.
Experience leading GCP deviation, CAPA, vendor qualification, and quality risk management in a GxP environment.
Strong analytical/critical thinking skills for risk evaluation and trend identification.
Excellent written, verbal, and interpersonal communication; ability to influence cross-functionally without direct authority.
Ability to manage multiple priorities in a fast-paced environment with high quality and attention to detail.
Benefits:
Competitive total rewards package including 401k, healthcare coverage, and ESPP.
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Worksite address
south san francisco, CA, 94083, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.