ABOUT THE JOB

We are seeking a highly skilled and experienced Global Quality Design & Qualification Lead for our newest program. This senior leadership position is vital in ensuring the highest standards of quality assurance and compliance throughout our state-of-the-art insulin manufacturing facilities in Europe and China. The role involves overseeing all aspects of Design & Qualification (D&Q) activities, with a focus on qualification, validation, and GMP compliance across the entire TIER 1 program lifecycle from feasibility to Process Performance Qualification (PPQ).
If you are passionate about leading quality assurance, commissioning, and qualification efforts in the pharmaceutical industry, have a strong background in biologic manufacturing, and possess the leadership skills to drive excellence in a complex, cutting-edge environment, we encourage you to apply for this exciting opportunity.

QUALIFICATIONS AND REQUIREMENTS:

• Advanced degree in Science/Engineering/Pharmacy or Equivalent (MSc or PhD preferred).
• Minimum of 8 years of industry experience, preferably in the biopharmaceutical sector for Commissioning, Qualification/Validation, with at least 5 years in a leadership position.
• In-depth knowledge of the biologic product license application process, and the associated regulatory requirements.
• Strong understanding of GMP compliance, quality systems, and risk management in pharmaceutical manufacturing.
• Proven experience in Quality System Management, Commissioning & Qualification, Process Validation Lifecycle, Quality by Design principles.
• Effective coaching and mentoring skills, with the ability to develop and lead high-performing teams.
• Proficiency in English is required; knowledge of German and French is highly desirable.

• Ensure proper execution of all aspects of Commissioning and Qualification (C&Q) activities, including qualification of facilities, critical utilities, equipment, and computerized systems.
• Define and oversee the program C&Q&V strategy, plans, and system impact assessments.
• Develop and implement comprehensive qualification/validation strategies and plans in line with regulatory requirements and industry best practices.
• Lead and actively participate in project workstreams related to qualification/validation strategies and quality processes for the InsuLINK program.
• Provide regular reporting to the Global Quality Program Lead and ensure project compliance with Sanofi standards and policies.
• Manage and mentor the quality assurance and D&Q project team, fostering a culture of excellence and continuous improvement.
• Collaborate with cross-functional teams to integrate quality considerations throughout the project lifecycle.
• Support regulatory inspections and audits, ensuring the project meets all applicable quality and compliance standards.
• Ensure strategic workforce planning of the D&Q organization during both project and routine manufacturing modes.
• Responsible for the InsuLINK D&Q budget and schedule, including regular collection of actual quality D&Q program cost and progress.