Manager GCP/GLP Governance

Details

  • Category: Pharmaceutical
  • Location: Western part of Switzerland
  • Starting date: Nov 01, 2017
  • Applications have closed
  • Domain of experience: Quality & GLP/GCP
  • Level required: Senior
  • Years of experience: Minimum 10 years

Your Role

As Manager GCP/GLP Governance will be part of the QMS Governance function. You will provide governance and compliance oversight of the facility through inspection management, audits, compliance upgrade projects working in a matrix dynamic and international organization.

Your Tasks

  • Ensure the full alignment of the regulations with functional strategy and its deployment within the team.
  • Lead the QA Unit for the GxP functions and ensure that all the studies are in compliance with the applicable GxP regulations
  • Establish and assess compliance with GxP regulations, through a risk based approach to audit planning
  • Accountable with the Test Facility Manager support that the GLP organization is prepared for inspections (hosting of the on-site inspections,  close collaboration with local authorities)
  • Responsible to oversee the GxP KPI reporting of the function
  • Foster and strengthen the quality mindset in the organization, through direct interaction with the GxP functions

Your Profile

  • Master degree in biology, chemistry, pharmacy or related field
  • Extensive experience in GCP QA environment
  • Exposure in a GLP environment is a plus
  • Experience in participation, management and hosting of external regulatory body inspections coupled with proven lead auditor experience
  • Experience in maintenance of QMSs and continuous improvement
  • Functional leadership and people development skills
  • Strong problem identification & solving and analysis skills
  • Excellent organizational skills with ability to plan complex projects and manage priorities efficiently

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