Senior Director, Clinical Quality Assurance Jobs in South San Francisco, United States

At Alector, our mission is to develop therapies that empower the immune system to combat neurodegeneration and cancer. Our team is solely focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, leading healthcare investors, and pharma company partnerswho share in our commitment to bettering the lives of patients.We are seeking a highly motivated individual to join as Senior Director, Clinical Quality Assurance at our South San Francisco location. The successful candidate will work cross-functionally to develop and implement quality systems and processes to meet all US, EU and potentially global, Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Distribution Practice (GDP), and Good Pharmacovigilance (GVP) requirements. The position will report directly to the Vice President, Quality.During the first year, your responsibilities and goals will include:Develop and implement GCP, GLP quality systems in accordance to ICH, FDA, EMA and global competent authority regulations and industry guidancesPrepare and implement audit plans and audit CAPAs for all CROs, testing and animal laboratories, clinical sites, and internal Alector departments.Lead and ensure inspection readiness activities for all internal and external entitiesLead and host GCP, GLP, GVP inspections. Follow up to any responses and CAPAsDevelop, implement and manage the deviation and CAPA systemsDevelop and implement overall GCP strategy, performance metrics, analytics and reportsDevelop the GCP QA organizational strategy and lead/mentor the respective teams

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