Lead, Third-Party Quality Audits (GxP)

Sanofi; Petaling Jaya; On-site; MYR 240,000 - 360,000; Full time

Job summary

Sanofi in Kuala Lumpur seeks a Third Party Audits Manager to lead QA audits of TPMs and CMOs, ensure cGMP compliance, and drive inspection readiness. You will coordinate with global quality teams, suppliers, and internal sites, plan audits, and deliver CAPAs.

You will mentor auditors, support RCA investigations, and propose improvements to strengthen third‑party quality. English is required; Mandarin/Japanese a plus. Join a global, impact‑driven team.

Qualifications

• Experience in quality auditing within pharmaceutical, biotech, or regulated manufacturing environments.
• Strong knowledge of FDA, EMA/regional requirements and ability to translate them into practical compliance assessments
• Proven audit and RCA/CAPA closure skills
• Excellent interpersonal and communication skills
• Analytical/problem-solving mindset with quality tools
• Ability to manage multiple audits and stakeholders
• Fluency in English; Mandarin/Japanese a plus

Responsibilities

• Organize, plan and perform quality audits of third parties.
• Provide independent assessment of third-party quality regarding material compliance and regulatory requirements.
• Identify gaps and communicate results with CAPA.
• Interface between third parties and sites to facilitate improvements and information exchange.
• Participate in qualification of new auditors and provide expertise on quality assessment.
• Support audits led by other auditors for specialized topics.
• Interact with Global Quality Third Parties Audit Management and related teams.
• Propose innovative solutions to improve third-party audit processes.
• Participate in Quality Documentation updates.
• Provide QA and technical support to TPMs and CMOs and related stakeholders.
• Ensure compliance with corporate and divisional QA policies and country regulations.
• Support RCA investigations and ensure CAPA closure.
• Lead the Quality Compliance team for cGMP compliance and inspection readiness.
• Manage supplier audit programs and follow up on regulatory audits.
• Oversee Regulatory Intelligence and contribute to Quality Risk Management on-site.
• Identify and propose process improvements.
• Track market developments and regulatory changes.
• Organize monthly reports and indicators for priority decisions.
• Conduct on-site and remote audits of GxP third-party vendors to ensure compliance.
• Collaborate regionally for inspection preparedness.

Skills

Quality auditing

Regulatory knowledge

Audit execution

Root Cause Analysis

CAPA management

Interpersonal skills

Analytical mindset

Project management

English proficiency

Mandarin/Japanese (plus)

Education

Scientific/engineering/pharma degree

Job description

Sanofi in Kuala Lumpur seeks a Third Party Audits Manager to lead QA audits of TPMs and CMOs, ensure cGMP compliance, and drive inspection readiness. You will coordinate with global quality teams, suppliers, and internal sites, plan audits, and deliver CAPAs.

You will mentor auditors, support RCA investigations, and propose improvements to strengthen third‑party quality. English is required; Mandarin/Japanese a plus. Join a global, impact‑driven team.