Job Description

About the job

Be part of a once-in-a-generation project that’s shaping the future of insulin.

Sanofi is building a cutting-edge, fully automated insulin drug substance facility in Frankfurt. Join us at the forefront of this global transformation. As part of a cross-functional program team, you’ll help bring this facility to life – from early design and construction through to readiness for commercial manufacturing

The Quality Manager IFF is responsible for ensuring that all aspects of Quality Assurance activities for the project are executed on time and in accordance with the project, 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 qualification/validation strategies, implementation of QMS measures in IFF 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:

• Ensure quality culture, quality mindset and quality GMP compliance performance and continuous improvement engaging all functions and organizational levels across the project and future sites to ensure that the requirements of GMPs are met.
• Deliver Quality activities in accordance with IFF planning & project needs, including writing, reviewing and releasing documentation as required.
• Responsible Quality Subject Matter Expert (SME) for the project on all matters related to Quality assurance, developing QMS IFF and assuring quality compliance in project execution.
• Actively engages in project team meetings, planning and scheduling meetings, and any related project requirements to ensure effective planning and execution of key Quality assurance deliverables.
• Support report on key project deliverables related to Quality assurance, ensuring a timely and effective communication and escalation of quality issues to the approriate levels of management.
• Support the review/approval of qualification and validation protocols and final reports (IQ, OQ, nP-PQ, etc).
• Support collection, validation, and migration of maintenance master data including functional locations, equipment records, spare parts, and maintenance plans
• Mentor and guide IFF Team Members (Project Teams) in appropriate Quality behaviors, recommending, highlighting systematic improvements to leadership and risk-based decision making to ensure success of the project.
• Supporting all relevant compliance inspections (e.g., Internal audits, Global Audits, Health Canada, FDA, HLfGP), and customer compliance inspection activities. This includes the responsibility of pre-inspection preparations, coordination of activities, participation in post-inspection responses, follow-ups, and the assurance of inspection reports to appropriate management personnel.
• Development, update and promotion Sanofi Global Quality Documentation and IFF GOPs or Global procedures.
• Contributes to the Digital strategy and transformation through appropriate communication with the project.

About you

• Education/Experience Ideally MSc Degree/Diploma in Science/Pharmacy or Equivalent; relevant industry experience, preferably within the biopharma and/or related regulated industry; In-depth knowledge of the biologic product license application process, and the associated regulatory requirements
• Soft and technical skills Practical experience in Quality System Management in Health regulated industry; Knowledge & experience in Pharmaceutical Manufacturing with production processing including automation, scientific writing, effective oral and written communication skills, and innovative thinking; Familiarity with strategic planning, balanced judgment and risk analysis; Technical skills: Quality systems, Quality Risk Management, Continuous improvement management, GxP and health regulated regulations, International and FDA exposure
• Languages proficiency in german and English required, additional languages welcome

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But 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. So, let’s be those people.

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

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

The salary range for this position is :€79.104,00 - €105.472

Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.