Job detail for Quality Control Support Specialist

Job Title: Quality Control Support Specialist

• Location: Ocoyoacac Plant

• Work model (remote, hybrid, on-site): On-site

About the Job

As a Quality Control Support Specialist within our Quality Control - M&S Vaccines Mexico team, you will be key in ensuring that the inputs used in the manufacturing of Monovalent Antigen Bulk meet the highest quality standards. You will lead sampling, inspection, and batch documentation review processes, ensuring compliance with Good Manufacturing Practices and actively contributing to a culture of continuous improvement. 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 innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people's lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

Key :

• Ensure compliance with Quality Systems, verifying adherence to Good Manufacturing Practices (GMP), Global Quality Directives, and corporate requirements in activities related to the review process of specific batch documentation for inputs (raw materials and materials), as well as the sampling and inspection of materials received at the plant facilities to perform the release of inputs used for the manufacturing of monovalent bulk, adhering to data integrity guidelines.

• Execute applicable processes within the SAP system related to inputs used for the manufacturing of Monovalent Antigen Bulk, ensuring compliance with applicable requirements and regulations.

• Manage the supplier complaint investigation process detected in the different Quality Systems, tasks, and Good Manufacturing Practices (GMP) operations, in accordance with applicable procedures and regulations. Notify critical events for escalation, and review investigations to ensure they are investigated with the appropriate depth and rigor to identify the root cause and corrective and preventive actions that prevent their recurrence.

• Participate as a Quality expert in Non-Significant deviations and invalid laboratory analysis investigations for the Quality Control area in accordance with applicable procedures, ensuring that the root cause is identified and that corrective and preventive actions are established to prevent their recurrence.

• Develop and implement risk management strategies to mitigate potential quality risks, fostering a culture of quality and continuous improvement throughout the organization.

• Participate in internal, external, and regulatory audits, providing support and required documentation.

• Monitor and analyze input management performance through performance metrics, implementing corrective actions when required.

About You

• Experience: - Background in Quality areas within the pharmaceutical industry, with participation in activities such as deviation follow-up, process inspection routines, area release, and process document review.

-Experience in supplier complaint management, root cause investigation, and definition of corrective and preventive actions (CAPAs).

-Participation in internal, external, or regulatory audits is a plus.

• Soft and technical skills:

-Expertise in Quality and Regulatory Compliance: Solid knowledge of GMP, Quality Assurance, Health Regulation, Data Integrity, and management of deviations and Change Controls.

-Risk Management and Analysis: Ability to identify discrepancies, perform root cause analysis, develop quality risk mitigation strategies, and implement CAPAs.

-Operational Competencies: Handling of ERP systems (SAP), knowledge of safety, hygiene, and biosafety, and experience in sampling, inspection, and document review processes.

-Interpersonal and Leadership Skills: Attention to detail, effective communication with cross-functional teams, proactivity to drive continuous improvements, and ability to work collaboratively in regulated environments.

• Education: Bachelor's degree in Chemistry, Pharmacy, Chemical Engineering, Biochemistry, or a field related to the Pharmaceutical Industry.

Professional Title and License (Cédula Profesional) are required.

• Languages: Intermediate level B2

Why Choose Us

• Bring the miracles of science to life alongside a supportive and future-focused team.

• Discover endless opportunities to develop your talent and advance 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 chase 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!

#LI-LAT #LI-Onsite

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!