Senior Director, Global GCP Inspection Lead

Vor 6 Tagen

Basel, Basel-Stadt, Schweiz BeiGene Vollzeit
Job Summary

We are seeking a highly experienced and skilled Senior Director, Global GCP Inspection Lead to join our team at BeiGene. This is a critical role that requires a deep understanding of GCP regulations and a proven track record of leading inspection readiness efforts.

Key Responsibilities
  • Lead cross-functional teams to ensure inspection readiness and compliance with GCP regulations
  • Develop and implement inspection readiness strategies and plans
  • Manage inspection logistics and process improvements to ensure research and development activities are conducted in accordance with applicable regulatory requirements
  • Collaborate with Quality Assurance, Clinical Operations, Pharmacovigilance, Clinical Business Operations, Biometrics, Medical Monitors, and Regulatory Affairs teams to ensure a unified approach to inspection readiness
  • Develop and maintain key QA systems, including investigations, Significant Quality Events (SQEs), Deviations, and CAPAs
  • Implement and maintain quality processes and procedures to ensure compliance with GCP regulations
  • Provide guidance and support to staff on GCP regulations and inspection readiness
  • Manage a central repository of global inspection status and updates
  • Lead and manage lessons learned sessions after inspections, identifying trends and best practices to implement process improvements
Requirements
  • BA/BS degree required
  • Expert knowledge of relevant FDA, EU, ICH GCP guidelines
  • Minimum of 7 years of experience in GCP-related Quality Assurance function of the pharmaceutical, biotechnology or related health care industry
  • High level of understanding of international GCP requirements and standards in the pharmaceutical, medical device and biotech industries
  • Excellent English language skills, and additional language depending on locations and need
  • Excellent verbal and written communication skills
  • Ability to effectively collaborate in a dynamic environment
Competencies
  • Fosters Teamwork
  • Provides and Solicits Honest and Actionable Feedback
  • Self-Awareness
  • Acts Inclusively
  • Demonstrates Initiative
  • Entrepreneurial Mindset
  • Continuous Learning
  • Embraces Change
  • Results-Oriented
  • Analytical Thinking/Data Analysis
  • Financial Excellence
  • Communicates with Clarity

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