M&S Quality Services, Third Party Audits Manager - KL Hub
On-sitePetaling Jaya, Selangor, Malaysia
Job Summary
Conduct GxP audits of Third Party Manufacturers and Contract Manufacturing Organizations, assessing material and regulatory compliance while identifying gaps for CAPA implementation. Lead root cause analyses for quality events, manage supplier audit programs, and oversee regulatory intelligence to ensure cGMP alignment and inspection readiness. Act as the local quality interface between suppliers, global teams, and internal sites to facilitate improvement follow-ups and exchange quality information. Coach new auditors, propose process innovations, and establish monthly reports to drive team effectiveness and continuous quality improvement across the hub.
Required Qualifications
- Experience in quality auditing within pharmaceutical, biotech, or regulated manufacturing environments
- 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)
- Ability to translate regulatory frameworks into practical compliance assessments
- Proven audit and investigative skills — able to plan, conduct, and report on-site or remote audits
- Ability to identify quality gaps
- Ability to 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
- Analytical and problem-solving mindset
- Comfortable using quality tools and systems to resolve complex compliance issues
- Ability to propose innovative process improvements
- Organizational agility to manage multiple audits, priorities, and stakeholders simultaneously
- A degree in a scientific, engineering, pharmaceutical, or related quality discipline
- Fluency in English
Desired Qualifications
- Proficiency in Mandarin or Japanese to the region/markets served
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