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SME Lead, Regulatory, Clinical R&D, Quality & Manufacturing San Francisco, CA 94105 5/30/2024

San Francisco, CA, United States

SME Lead, Regulatory, Clinical R&D, Quality & Manufacturing Must have 10+ Years ofrelevant experience

Leadthe R&D Quality and Manufacturing team to manage GCP (good clinicalpractice) and GPV (good pharmacovigilance practices) inspections by globalregulatory health authorities.

Providestrategies and oversight for global planning-preparations and clinicalinvestigations.

Buildsystems and tools to support and oversee end-to-end inspection readinessand inspection management training.

Developstaff competencies and capabilities in inspection readiness, inspectionconduct, and CAPAs. Collaboratewith teams and SMEs to investigate and resolve inspection readiness gapsprior, during and post inspection. SupportCAPA development and perform CAPA effectiveness checks for inspectionfindings.

Contributeregulatory and quality strategies for the preparation of inspection riskassessments for senior management and key stakeholders.

ReviewQMS (Quality Management System) policies and processes for inspection readiness

Provideas-needed liaison to client’s partner and vendor inspections.

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