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.
- 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
- 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