M&S Quality Services, Third Party Audits Manager - KL Hub

• Organize, Plan & Perform Quality Audits of Third Parties, upon request according to annual audit program in place.

• Provide an independent assessment of Third Parties quality in place with regards to material compliance, as well as regulatory and quality requirements.

• Identify gaps and area of improvements, communicate results if needed and ensure the availability of CAPA for complete communication.

• Interface between the Third Parties and sites using them to facilitate follow up of improvements and exchange of quality information.

• Participate in qualification of new auditors in the hub, by performing audits with them and providing expertise regarding quality assessment of Third Parties.

• Support audits led by other auditors when specific expertise is needed (e.g. for cause audit with user site representative, highly sophisticated topics).

• Interact with Global Quality Third Parties Audit Management and Third Parties Quality Management colleagues for enhancement as & when required.

• Propose innovative solution to improve Third Parties Quality Audit process as & when required.

• Participate to Quality Documentation update as & when required.

• Provide QA and Technical Support to Third Party Manufacturers (TPM) and Contract Manufacturer Organizations (CMO), TPM/CMO Operations, Affiliates, and other Stakeholders.

• Responsible for compliance with Corporate and Divisional QA policies, procedures, standards, and specifications as well as country specific regulations depending on the TPM/CMO location and markets.

• Ensure compliance to Corporate and Divisional QA requirements and identify and / or resolve Quality gaps and / or issues relating to product design, manufacturing quality programs and product start-ups at TPM’s and CMO’s.

• Support Root Cause Analysis (RCA) investigations of quality events as required

• Utilize understanding of QA systems and problem-solving tools to provide alternative solutions to quality issues.

• Lead the Quality Compliance team ensuring cGMP compliance and inspection readiness.

• Manage supplier audit programs and follow-up on regulatory audits.

• Oversee Regulatory Intelligence and contribute to Quality Risk Management (GRT) on-site.

• Identify and propose process and procedure improvement proposals.

• Manage supplier audits, ensuring cGMP and SOP alignment.

• Track market developments, regulatory changes.

• Contribute to team effectiveness, identify risks, formulate improvements.

• Manage work processes efficiently, respect laws.

• Follow up on CAPA’s.

• Proactively monitor FDA, EMA requirements, share knowledge.

• Coach and direct the team, conduct evaluation interviews, and assess training needs.

• Provide an assessment of supplier’s quality in place with regards to material compliance, as well as regulatory of CAPA for Third Party sites

• Being a local quality contact between the Suppliers, Global Quality Suppliers & IA sites to facilitate exchange of quality information

• Support audits lead by other auditors when specific expertise is needed (e.g. for cause audit with user sites representatives, highly sophisticated topic)

• Organize day to day agenda according to workload defined by the group. Establish monthly reports and indicators for priority decisions.

• Conduct on-site and remote audits of GxP and Health Regulated Third Party vendors to ensure compliance with regulations and company policies.

• Prioritize audit planning to meet audit, assessment, and monitoring plans.

• Collaborate with stakeholders regionally for inspection preparedness.

About You •

Fluency in English is required; proficiency in Mandarin or Japanese to the region/markets served is a plus

Why Choose Us?

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— Be part of a world-leading pharmaceutical company where your quality expertise directly protects patients and ensures the highest standards of medicine reach people who need them most

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— Work alongside passionate quality professionals, global audit teams, and cross-functional stakeholders in a truly international environment that values diverse perspectives

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— Expand your expertise by mentoring new auditors, engaging with sophisticated quality topics, and contributing to innovative process improvements that shape the future of third-party quality management

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— Thrive in an environment driven by cutting-edge science, where your regulatory knowledge and audit skills are continuously challenged and sharpened

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— Take ownership of critical compliance programs, lead cGMP initiatives, and play a pivotal role in inspection readiness — your work truly matters

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— Sanofi encourages you to challenge the status quo, propose smarter audit solutions, and contribute to a culture of continuous quality improvement

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