QMS Implementation

Reporting to the Quality Systems & Governance team, you will lead transformation projects in a transversal sprint mode to rethink, harmonize, and simplify quality documentation and global processes. Your responsibilities include:

• Quality Standards Development: Analyzing applicable GxP regulations, defining the company's position, and translating it into clear, structured, and actionable quality standards.
• QMS Transformation Sprints Management: Defining the scope, facilitating workshops with business experts, identifying duplicates/gaps, and driving the simplification of processes and controlled documents.
• Governance and Matrix Alignment: Facilitating decision-making, managing risks, and ensuring the link between the global vision and practical implementation in local entities.
• Adoption and Change Management: Integrating training, communication, and change management needs from the design of solutions to ensure their sustainability.
• Use of Digital Tools & AI: Leveraging approved AI capabilities for regulatory analysis and drafting, while ensuring rigorous human control.

• Education: Bachelor's or Master's degree (Life Sciences, Engineering, Quality, or equivalent).
• Experience & Expertise: Solid knowledge of QMS systems and GxP requirements in the biopharmaceutical industry. Proven experience in managing transversal transformation projects (sprints, process simplification).
• Key Skills: Excellent technical writing skills, critical thinking, influencing skills without direct authority in a complex matrix environment.
• Language: Fluent in English (oral and written).

• Status: Consultancy assignment.