Responsibilities
- Lead the integration of the Quality Management System (QMS), including documentation and training activities related to the transfer of operations.
- Define and manage documentation scopes associated with transferred activities.
- Support teams in the drafting, review, and continuous improvement of quality documents, including SOPs, procedures, and forms.
- Ensure harmonization of documentation practices across impacted sites.
- Coordinate documentation activities and monitor project timelines to ensure successful delivery.
- Track action plans, identify risks and bottlenecks, and implement mitigation actions to maintain project milestones.
- Manage training activities from needs identification through content development, delivery, and effectiveness assessment.
- Support change management initiatives by facilitating adoption of new processes and addressing resistance to change.
- Coordinate quality events linked to the project, including Change Controls, CAPAs, and deviations.
- Develop and monitor project KPIs and maintain quality trackers to ensure project visibility and compliance.
Requirements
- 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.
Core Competencies
Demonstrates expertise in Quality Management Systems (QMS) within GMP-regulated environments, with a strong focus on documentation management, training activities, and project coordination. Proven ability to drive quality improvement initiatives and manage cross-functional teams effectively.
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Quality Manager in Gidy employeur : Excelya
Notre entreprise de santé se distingue par son engagement envers l'innovation et l'excellence, offrant un environnement de travail collaboratif où chaque employé peut contribuer à des projets significatifs. Nous valorisons le développement professionnel avec des opportunités de formation continue et un soutien à la croissance de carrière, le tout dans un cadre stimulant et respectueux des normes GMP. Rejoindre notre équipe, c'est faire partie d'une mission qui a un impact direct sur la vie des patients, tout en bénéficiant d'un équilibre travail-vie personnelle optimal.
