Global Quality D&Q Lead InsuLINK (all genders)

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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.

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