Manufacturing and Supply
Wo Wunder der Wissenschaft
für Patient*innen Realität werden

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About the job

The Quality Data Integrity & VEX Manager IFF is responsible for ensuring that all aspects of Data Integrity and validation activities for the project, including design, qualification of facilities, critical utilities, equipment, and computerized systems, automation and digitalization, are executed on time and in accordance with the C&Q / Validation Master Plan, local and global requirements, and applicable regulations.

As an integral part of the project quality team, this position has overall responsibility for participating in project workstreams, ensuring proper execution of design/qualification/validation strategies as well as providing support and guidance for quality processes and procedures. 

This role is expected to work independently and with a level of autonomy and authority in decision-making to ensure on-going compliance against approved documents and current Good Manufacturing Practices across the project during conceptional, basic and detailed design, construction C&Q, PQ, Validation and future site organizations until final approval. 

Main responsibilities:

• Lead and oversee all aspects of data integrity and computerized system (CS) validation in commissioning, qualification, and validation activities for the IFF project, ensuring compliance with Sanofi standards, good practices, and regulatory requirements. 

• Drive Data Integrity Strategy in IFF in collaboration with Automation, MSAT, Operations and CQ team, with focus on data integrity in GxP alarms, electronic Batch release, Quality data processing in IFF.

• Oversee as Quality the Strategy and Execution of Automation and computerized Equipment Design, Automation C&Q and integration in C&Q&V, code testing, integration and documentation by external vendors.

• Ensure Automation qualification and CS Validation in IFF compliant to Annex 1, Annex 15, GAMP and applicable regulations  

• Develop and implement the project's data integrity, commissioning, qualification, and validation strategy and plans. 

• Review and approve validation protocols and reports to maintain quality standards. 

• Provide expert quality guidance and mentorship to the project team, fostering a culture of compliance and continuous improvement. 

• Support compliance inspections and audits, ensuring the project meets all regulatory requirements. 

• Collaborate with cross-functional teams to ensure quality objectives are met throughout the project lifecycle. 

• Actively participate in project workstreams, providing expert guidance on quality processes and procedures related to data integrity, automation, and digitalization.

Why choose us?:

• Opportunity to work on a major investment program building new large-scale insulin facilities in Europe and China

• Chance to contribute to state-of-the-art, fully GMP compliant biologics plants 

• Collaborative and innovative work environment 

• Competitive salary and benefits package 

• Professional development and growth opportunities 

• Chance to make a significant impact on global health through quality management in insulin production 

About you

• Education/Experience: Degree in Engineering, Science, Pharmacy, or equivalent field. MSc in Engineering preferred; 3-5 years of industry experience in biopharma or related regulated industry, specifically in computerized system validation, commissioning, qualification/validation; Expertise in quality systems, risk management, and continuous improvement methodologies

• Soft and technical skills: In-depth knowledge of biologic product license application processes and regulatory requirements around data integrity, validation, automation, and digitalization; Strong understanding of pharmaceutical manufacturing processes, particularly in large-scale biologics plants for bacterial processes; Experience with quality data integrity, validation execution strategy, and GMP compliance; Excellent leadership, communication, decision-making, and people development skills

• Languages: Proficiency in English is required; knowledge of German and French is a plus

Pursue Progress. Discover Extraordinary.

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