Microbiology Quality Control Manager (all genders)

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About the job

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

As part of a cross-functional program team, you'll help bring a new facility to life - from early design and construction through to readiness for commercial manufacturing. Your work will help turn the miracles of science into reality for millions living with diabetes.

Position Overview

Being the Interface to the MQC-Lab of the Future project, the Microbiology Quality Control Manager IFF provides leadership for Quality Control lab during all project phases and future site organizations until final approval.

Endorse micro quality control lab decisions at project level, participate in the development of the project and future sites strategy:

Ensures the quality control of Sanofi products in a complex environment and within the strongly regulated area of the production of active substances with the chosen quality strategy, the applied processes and technologies as well as the appointed personnel. Assurance of sustainable compliance of the project with legal and quality requirements by continuous consideration of further and new developments in regulatory requirements. Assurance of the most effective use of the available resources for quality control.

Main responsibilities:

• Lead the Microbiology Quality Control lab team by providing appropriate training, mentoring, review and development to ensure retention of talented people and robust succession planning across key positions.
• Provide leadership, strategic guidance and recommend policies, procedures, and activities ensuring robust quality control and product protections are in place.
• Responsible for the delivery of micro quality control lab aspects of the project, within the allocated budget, schedule and the expected objectives, performances, HSE, Quality
• Manage micro quality control lab team consisting of internal and external experts in close cooperation with the Frankfurt BioCampus (FBC)
• Ensure the project is performed according to the Sanofi Standard and Good Practices
• Guarantee regular reporting to the Global Contamination Control and Micro Qaulity Control Project Lead Insulink
• Maintain development and validation of micro methods as well as transfer of methods to IFB in close cooperation with the FBC
• Ensure execution of project C&Q&V strategy, C&Q&V plans and System impact assessment
• Oversee lab readiness to perform the needed activities in the project phases while Interacting with the 2 InsuLINK sites to keep benchmark and best practices.

About you

• Education/Experience: MSc or PhD degree or equivalent in natural sciences, ideally Microbiology/Pharmacy; experience in Leadership positions with a proven track record of delivery and compliance; significant industry experience, preferably within the Mirobiology Quality Control or Sterility Assurance position at an industrial site; In-depth knowledge of the biologic product license application process, and the associated regulatory requirements including Annex 1 knowledge in production and development of active substances and drug product (e.g. Steriles, Vaccines and Biotechnology)
• Soft and technical skills: Leadership and assertiveness skills; knowledge of Quality systems, Quality Risk Management, Continuous improvement management, GxP and health regulated regulations, International and FDA exposure
• Languages: proficiency in German and English required

Diversity und Inklusion sind in den Grundwerten von Sanofi verankert und spiegeln sich in unserer Arbeitsweise wider. Wir respektieren die Vielfalt unserer Belegschaft in Hinsicht auf ihre Herkunft, Erfahrungen und Lebensweisen. Wir erkennen die Bereicherung, die diese Vielfalt birgt, und fördern Inklusion sowie eine Arbeitsumgebung, in der diese Unterschiede sich weiter entwickeln können, zur Stärkung des Lebens unserer Mitarbeiter, Patienten und Kunden.