Data Integrity & CS Vex Manager (all genders)

Sanofi EU; Frankfurt; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading company in biopharma seeks a Quality Data Integrity & VEX Manager IFF to oversee validation activities and ensure compliance with quality standards. This role involves leading data integrity strategies, mentoring project teams, and collaborating across functions in a dynamic environment. The ideal candidate will have a degree in Engineering or Science, with 3-5 years of relevant industry experience, and strong leadership skills.

Leistungen

Competitive salary and benefits package

Professional development and growth opportunities

Collaborative and innovative work environment

Opportunity to work on major investment programs

Qualifikationen

• 3-5 years of industry experience in biopharma or regulated industry.
• Expertise in computerized system validation and quality systems.
• Proficiency in English; knowledge of German and French is a plus.

Aufgaben

• Lead data integrity and computerized system validation for the IFF project.
• Develop and implement data integrity and validation strategies.
• Collaborate with cross-functional teams to meet quality objectives.

Kenntnisse

Leadership

Communication

Decision-making

People development

Ausbildung

Degree in Engineering, Science, Pharmacy or equivalent

MSc in Engineering

Jobbeschreibung

To ensure a rapid processing of your application, please apply only via the “Apply” button. Please include a letter of motivation and a current resume with your application.

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

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing : a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion !

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Integrity Cs Vex All • Frankfurt am Main, Germany