Job detail for Qualification and Validation Lead

Job Title: Qualification and Validation Lead

• Location: Cuautitlán Plant, Mexico
• Work model: On-site

About the Job

As a Qualification and Validation Lead, you will be responsible for leading, coordinating, and supervising all computerized system validation and equipment qualification activities for the process transfer project of the Hexacima product from Val de Reuil (France) to Cuautitlán (Mexico). You will ensure compliance with local (COFEPRIS) and global (Sanofi standards) regulatory requirements during the secondary packaging (Phase 1) and aseptic filling, visual inspection, and packaging (Phase 2) stages. You will act as the technical point of contact between Engineering, Quality, Manufacturing, Suppliers, and Contractors to ensure the successful execution of the project's master validation plan. Ready to get started?

Join a global network that drives how Sanofi delivers its products, seamlessly, intentionally, and at scale. In M&S, you will help reimagine how life-changing treatments reach people everywhere, faster.

About Sanofi:

We are an R&D-driven and AI-powered company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline allows us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we pursue the miracles of science to improve people's lives.

Key :

Develop and manage the Validation Master Plan (VMP) for the Hexacima project, aligned with the GARAMP schedule and technology transfer phases, keeping milestones, deviations, and corrective actions updated.

• Lead the validation of critical GxP computerized systems (CSV) in accordance with 21 CFR Part 11, GAMP 5, and ALCOA+ principles, including process control systems (PCS), building automation systems (BAS), and traceability, risk, and test protocol management.

• Coordinate and supervise the qualification of new and existing equipment (DQ, IQ, OQ, PQ), including aseptic filling lines, autoclaves, washers, HVAC systems, cold rooms, compressed air, and automatic visual inspection equipment.

• Manage external contractors and suppliers, reviewing and approving validation deliverables (URS, DQ, FAT, SAT, IQ, OQ, PQ), managing contracts, scopes of work, schedules, and budgets associated with validation services.

• Ensure regulatory compliance of all validation activities in accordance with GMP, 21 CFR Part 11, GAMP 5, ISPE, ISO 14644, NOM-059-SSA1, and COFEPRIS, providing support during regulatory audits (COFEPRIS, FDA) and internal and global inspections.

• Act as a cross-functional technical point of contact between Engineering, Quality, Manufacturing, Supply Chain, and Contractors, coordinating area availability, validation batch execution, warehouse qualification, and equipment commissioning.

• Manage validation documentation in QMS and electronic systems such as QualiPSO, including CCRs, CAPAs, deviations, non-conformities, training matrices, and progress reports for the project team and leadership.

About You

Experience: 7 to 10 years of previous experience in computerized system validation and equipment qualification in GMP pharmaceutical manufacturing environments, with demonstrable experience in: Large-scale technology transfer or CAPEX projects, aseptic process validation (filling, sterilization, media fills), leading cross-functional teams and contractor management, regulatory audits (FDA, EMA, COFEPRIS).

Soft and technical skills:

• Knowledge of GxP equipment and system validation and qualification, including CSV, 21 CFR Part 11, GAMP 5, ALCOA+, IQ/OQ/PQ, FAT/SAT, and commissioning.
• Mastery of regulations and risk management, including GMP, ISPE, ISO 14644, NOM-059-SSA1, Annex 1, ICH Q9, FMEA, and impact analysis.
• Experience in documentation and project management, handling electronic quality systems such as QualiPSO, agile methodologies, schedules, budgets, and stakeholders; knowledge of vaccine manufacturing is desirable.
• Technical leadership skills and the ability to influence cross-functional teams without direct authority.
• Analytical capacity and ability to solve complex problems in high-pressure environments and tight schedules.

Education: University degree in Engineering (Chemical, Biochemical, Industrial, Electrical, Electronic, Mechatronic) or QFB with a specialization or postgraduate degree in Validation, Computerized Systems, or Pharmaceutical Engineering (desirable).

Languages:

• Intermediate-Advanced English (reading, writing, speaking) - essential for coordination with the Val de Reuil (France) team and review of technical documentation in English.
• Basic French - desirable.

Why Choose Us

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to develop your talent and drive your career, whether through a promotion or a lateral move, locally or internationally.
• Enjoy a well-designed and thoughtful benefits package that recognizes your contribution and boosts your impact.
• Shape the future of medicine and vaccine distribution with cutting-edge technology, ensuring smooth launches and a resilient global supply chain.
• Drive industry-leading performance by leveraging digital innovation, data, and artificial intelligence, with speed and at scale.
• Transform lives around the world by delivering life-changing treatments anywhere, anytime.

Pursue Progress. Discover Extraordinary.

Join Sanofi and enter a new era of science - where your growth can be as transformative as the work we do. We invest in you to go further, think faster, and do what has never been done before.

You will help push boundaries, challenge conventions, and build smarter solutions that reach the communities we serve. Ready to pursue the miracles of science and improve people's lives? Let's pursue Progress and Discover the Extraordinary – together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity, Equity, and Inclusion actions at sanofi.com!

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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.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!