Senior Manager, Gcp Inspection Lead

BeOne Medicines

Switzerland
Base: 141,800.00 chf - 177,300.00 chf; bonus/equit...
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7+ years gcp quality assurance experience
Health authority inspection leadership
Fda mhra ema regulatory compliance
** BeOne Medicines is seeking a Senior Manager, GCP Inspection Lead, to oversee inspection readiness for health authority inspections within cross-functional clinical study teams. The ideal candidate will have significant experience in GCP-related quality assurance, strong leadership capabilities, and a collaborative spirit, with a focus on ensuring compliance with global regulatory requirements. **

Job Summary

  • This role serves as the primary inspection lead for Health Authority GCP inspections across cross-functional clinical study teams.
  • The position requires managing end-to-end inspection readiness activities including logistics, stakeholder coordination, and continuous process improvements.
  • Candidates must possess a thorough understanding of global regulatory requirements governing clinical trial operations across multiple regions.

Matching Summary

Match Score: 75

** BeOne Medicines is seeking a Senior Manager, GCP Inspection Lead, to oversee inspection readiness for health authority inspections within cross-functional clinical study teams. The ideal candidate will have significant experience in GCP-related quality assurance, strong leadership capabilities, and a collaborative spirit, with a focus on ensuring compliance with global regulatory requirements. **

Salary

Base: 141,800.00 CHF - 177,300.00 CHF; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • 7+ years GCP Quality Assurance experience
  • Health Authority inspection leadership
  • FDA MHRA EMA regulatory compliance
  • Risk-based inspection readiness strategy
  • Mock inspection facilitation and execution
  • SOP development and QA system maintenance

Nice-to-have

  • Cross-functional collaboration skills
  • Mentoring and team development capabilities
  • Strategic direction definition
  • Excellent verbal and written communication
  • Ability to work in fast-paced environment

Key Requirements

  • +7 years of experience in GCP-related Quality Assurance
  • High level of understanding of international GCP requirements
  • Flexible to travel up to 35% internationally

Work Rights

Not specified

Tailored Resume

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