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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.

Key Responsibilities:

• 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.

About you

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.

Key Competencies:

• Strong analytical and problem-solving skills

• Excellent project management and organizational abilities

• Outstanding communication and interpersonal skills

• Ability to work effectively in a fast-paced, dynamic environment

• Adaptability and willingness to embrace new technologies and methodologies

• Strategic thinking and decision-making capabilities

• Strong negotiation and business partnering skills

• Attention to detail and commitment to maintaining high-quality standards

What We Offer:

• Opportunity to lead quality assurance and D&Q efforts in a major investment program for new large-scale insulin facilities

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

• Collaborative and innovative work environment

• Competitive salary and benefits package

• Professional development and growth opportunities

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

Key Challenges:

• Managing the complexity of establishing quality systems and D&Q processes for large-scale insulin manufacturing facilities in Germany and China

• Implementing and overseeing validation strategies for cutting-edge pharmaceutical technologies

• Ensuring compliance with evolving regulatory requirements in multiple jurisdictions

• Balancing quality assurance needs with project timelines and budgetary constraints

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.

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