SME Lead, Regulatory, Clinical R&D, Quality & Manufacturing

Job Description

Must have 10+ Years of relevant experience

  • Lead the R&D Quality and Manufacturing team to manage GCP (good clinical practice) and GPV (good pharmacovigilance practices) inspections by global regulatory health authorities.
  • Provide strategies and oversight for global planning-preparations and clinical investigations.
  • Build systems and tools to support and oversee end-to-end inspection readiness and inspection management training.
  • Develop staff competencies and capabilities in inspection readiness, inspection conduct, and CAPAs. Collaborate with teams and SMEs to investigate and resolve inspection readiness gaps prior, during and post inspection. Support CAPA development and perform CAPA effectiveness checks for inspection findings.
  • Contribute regulatory and quality strategies for the preparation of inspection risk assessments for senior management and key stakeholders.
  • Review QMS (Quality Management System) policies and processes for inspection readiness
  • Provide as-needed liaison to client’s partner and vendor inspections.

Work Schedule

  • Full time (40 hrs/week)
  • 4 days/week on-site
  • Remote for remaining time
  • Location: San Francisco Bay Area
  • Duration: 6 months

Type: Contractor

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Protocol Link, Inc.

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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