QMS Quality Manager
On-siteGidy, Centre, France
Job Summary
Lead the integration of the Quality Management System (QMS) and documentation processes for the strategic site transformation project at the Gidy site. Define documentation scopes, support teams in drafting and reviewing SOPs, and ensure harmonization of practices across impacted sites. Coordinate quality events including Change Controls, CAPAs, and deviations while tracking action plans, identifying risks, and implementing mitigation actions to maintain project milestones. Manage training activities from needs identification through delivery and effectiveness assessment, and develop project KPIs to ensure visibility and compliance with GMP requirements.
Required Qualifications
- Master's degree in Quality Assurance, Life Sciences, Pharmacy, Engineering, or a related field
- Strong experience in Quality Management Systems (QMS) within a GMP-regulated environment
- Strong knowledge of Quality Management Systems, GMP requirements, CAPA management, Change Controls, and deviations
- Experience in document management, SOP creation, and quality documentation review
- Proven ability to coordinate cross-functional teams and manage complex projects
- Good IT affinity, including Microsoft Office tools and quality management systems
- Experience monitoring KPIs and driving quality improvement initiatives
- Good level in English
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