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. 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 • Experience in quality auditing within pharmaceutical, biotech, or regulated manufacturing environments, with hands-on exposure to GxP/cGMP audits of Third Party Manufacturers or Contract Manufacturing Organizations • Strong knowledge of regulatory frameworks (FDA, EMA, and applicable regional health authority requirements) and ability to translate them into practical compliance assessments • Proven audit and investigative skills — able to plan, conduct, and report on-site or remote audits, identify quality gaps, and drive Root Cause Analysis (RCA) and CAPA follow-up to closure • Excellent interpersonal and communication skills to act as a trusted interface between Third Parties, internal sites, and global quality teams, building collaborative relationships that support continuous improvement • Analytical and problem-solving mindset , comfortable using quality tools and systems to resolve complex compliance issues and propose innovative process improvements • Organizational agility to manage multiple audits, priorities, and stakeholders simultaneously, adapting plans based on workload and inspection readiness needs • Education: A degree in a scientific, engineering, pharmaceutical, or related quality discipline is expected, as it underpins the technical judgment needed for compliance assessments • Languages: Fluency in English is required; proficiency in Mandarin or Japanese to the region/markets served is a plus Why Choose Us? • 🌍 Global Impact — 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 • 🤝 Coll…