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

Job title : M&S Quality Services, Third Party Audits Manager - KL Hub Location:  Kuala Lumpur About the job: This role drives quality assurance across Third Party Manufacturers and Contract Manufacturing Organizations by planning and executing GxP audits, assessing regulatory compliance, and identifying gaps with actionable CAPAs. The position serves as a critical interface between suppliers, global quality teams, and internal sites, ensuring cGMP alignment and inspection readiness. Responsibilities include supporting root cause analyses, monitoring FDA/EMA regulatory changes, coaching auditors, and proposing innovative process improvements to continuously elevate third-party quality standards. Job Description: • 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.