SME Lead, Regulatory, Clinical R&D, Quality & Manufacturing
San Francisco, CA, United States
SME Lead, Regulatory, Clinical R&D, Quality & Manufacturing Protocol Link, Inc.
10/17/2023
Job Description 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.
Headquartered in Chicago metropolitan area, Protocol Link is a leading project management and strategy consulting firm providing comprehensive regulatory affairs, cGMP compliance, quality assurance, and validation services to the FDA-regulated companies worldwide. Protocol Link’s mission is to provide customer-focused services with ethical conduct, mutual trust, and personnel empowerment while striving to offer the best of both quality and efficiency. It's how we've been doing business since 1996. The right way.
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