Third-Party Quality Audit Lead — cGMP & Compliance

Sanofi; Kuala Lumpur; On-site; MYR 180,000 - 300,000; Full time

Job summary

Sanofi in Kuala Lumpur seeks a M&S Quality Services, Third Party Audits Manager to lead GxP audits of TPMs/CMOs, ensuring cGMP alignment and inspection readiness across regional partners. You will organize an annual audit program, assess regulatory compliance, identify gaps, and drive CAPA closure, while coaching auditors and collaborating with global quality teams.

Ideal candidates bring pharma QA audit experience, strong regulatory knowledge (FDA/EMA), and the ability to communicate quality

Qualifications

• Experience in quality auditing within pharmaceutical or regulated manufacturing environments.
• Hands-on exposure to GxP/cGMP audits of third party manufacturers or contract manufacturers.
• Strong knowledge of regulatory frameworks (FDA/EMA) and ability to translate them into practical assessments.

Responsibilities

• Organize, plan and perform quality audits of third parties per annual program.
• Provide independent quality assessment of third parties for material compliance and regulatory requirements.
• Identify gaps and drive CAPA closure; communicate results to stakeholders.
• Lead QA teams to ensure cGMP compliance and inspection readiness; manage supplier audit programs.

Skills

Quality auditing

GxP audits

CAPA

RCA

Regulatory knowledge

Auditor coaching

Education

Science/Engineering/Pharma degree

Job description

Sanofi in Kuala Lumpur seeks a M&S Quality Services, Third Party Audits Manager to lead GxP audits of TPMs/CMOs, ensuring cGMP alignment and inspection readiness across regional partners. You will organize an annual audit program, assess regulatory compliance, identify gaps, and drive CAPA closure, while coaching auditors and collaborating with global quality teams.

Ideal candidates bring pharma QA audit experience, strong regulatory knowledge (FDA/EMA), and the ability to communicate quality