M&S- Commissioning and Qualification Lead IFB

Job description

Job Description : CQV Leader - Large Scale Insulin Project - IFB Position Overview : We are seeking an experienced "Commissioning and Qualification (C&Q) Leader" to lead validation activities for a large-scale insulin manufacturing project. This role requires a strategic leader with deep technical expertise, regulatory knowledge, and proven ability to manage complex greenfield projects in a multicultural environment. Key Responsibilities : Strategic Leadership & Project Management Lead and oversee all CQV activities for the large-scale insulin manufacturing facility from design through to commercial readiness Develop and implement risk-based validation strategies aligned with ICH Q9 and regulatory expectations Build, structure, and manage a high-performing CQV team to execute project deliverables on time and within budget Drive cross-functional collaboration across Engineering, Quality, Operations, Regulatory Affairs, and external partners Establish project governance, KPIs, and reporting mechanisms to ensure transparency and accountability Risk-Based Approach & Compliance : Apply risk-based methodologies (FMEA, HACCP, risk assessments) to prioritize validation activities and optimize resource allocation Ensure all CQV activities comply with global regulatory requirements (FDA, EMA, WHO, ICH guidelines) Lead preparation for and successfully navigate international regulatory inspections and audits Maintain comprehensive validation documentation and ensure traceability throughout the project lifecycle Technical Expertise & Execution : Oversee commissioning, qualification (IQ/OQ/PQ), and validation of facilities, utilities, equipment, and processes for insulin production Lead Computer System Validation (CSV) activities for critical manufacturing and laboratory systems Champion the implementation and utilization of "KNEAT" digital validation platform to streamline CQV workflows and documentation Ensure validation protocols and reports meet regulatory standards and internal quality requirements Support technology transfer activities and process validation for insulin manufacturing Stakeholder Management : Build and maintain strong relationships with internal stakeholders across all organizational levels and functions Manage external vendors, consultants, and contractors to ensure alignment with project objectives Communicate effectively with senior leadership, providing regular updates on progress, risks, and mitigation strategies Collaborate with global teams and navigate multicultural working environments with cultural sensitivity Required Qualifications : Education & Experience : Bachelor's or Master's degree in Engineering (Chemical, Mechanical, Pharmaceutical, Biotechnology, or related discipline) Minimum 10+ years of progressive experience in CQV within pharmaceutical/biopharmaceutical manufacturing Proven experience in greenfield projects, preferably in large-scale biologics or insulin manufacturing facilities Experience working in multinational companies (MNC) with exposure to global standards and practices Technical Competencies : Expert knowledge of risk-based validation approaches** and regulatory guidelines (ICH Q7, Q8, Q9, Q10, FDA 21 CFR Part 11, EU GMP Annex 11, 15) Extensive experience with KNEAT digital validation platform** for managing CQV documentation and workflows Strong knowledge of Computer System Validation (CSV) including GAMP 5 principles and data integrity requirements Deep understanding of aseptic processing, sterile manufacturing, and biologics production (insulin manufacturing preferred) Experience with validation of utilities (HVAC, WFI, clean steam, compressed air), equipment, and automated systems Regulatory & Audit Experience : Demonstrated success in facing and leading international regulatory audits (FDA, EMA, WHO, Health Canada, etc.) Ability to prepare audit-ready documentation and respond effectively to regulatory observations Strong understanding of global regulatory landscape and regional requirements Leadership & Soft Skills : Exceptional leadership abilities with proven track record of building and developing high-performing teams Outstanding stakeholder management skills with ability to influence and align diverse groups Strong communication skills (written and verbal) in English; additional languages are an asset Cultural intelligence and adaptability to work effectively in multicultural, global environments Strategic thinking with strong problem-solving and decision-making capabilities Ability to work under pressure, manage multiple priorities, and deliver results in fast-paced environments Preferred Qualifications: Experience with continuous process verification (CPV) and lifecycle validation approaches Knowledge of Industry 4.0 technologies and digital transformation in pharmaceutical manufacturing Certification in project management (PMP) or Six Sigma (Green/Black Belt) Experience with other digital validation tools and electronic quality management systems (eQMS) Previous experience in insulin or other biologics manufacturing environments What We Offer : Opportunity to lead a strategic, high-impact project in a world-class pharmaceutical organization Collaborative, innovative work environment with global exposure Professional development and career growth opportunities Competitive compensation and benefits package Chance to contribute to life-changing therapies for patients worldwide Location : IFB - Project site Beijing, Beijing with limited local & international Travel Reports To Project Execution Lead. Note : # We are committed to diversity and inclusion. We encourage applications from candidates of all backgrounds and experiences. Pursue progress, discover extraordinaryBetter 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!