M&S Quality Services, Third Party Audits Manager - KL Hub at Sanofi-Aventis - Selangor

The M&S Quality Services, Third Party Audits Manager is responsible for performing GxP Quality Audits of various Third Parties. This role plays a critical part in ensuring supplier quality and compliance with regulatory and quality requirements across multiple regions.

In this role, you will engage in day-to-day audits and assessments of third-party suppliers, ensuring adherence to quality standards and regulatory compliance. You will work closely with various stakeholders to facilitate communication and improve audit processes.

Key Responsibilities:

• Perform GxP Quality Audits of Third Parties including Pharmaceutical Starting Materials, APIs, Excipients, and Drug Product Manufacturers.
• Provide independent assessments of supplier quality and compliance with regulatory requirements.
• Manage audit programs and facilitate communication between third parties and Sanofi sites.
• Contribute to the qualification of new auditors and support regulatory inspections.
• Propose improvements to audit processes and ensure adherence to corporate quality standards.
• Conduct on-site audits and inspections, handling regulatory/health authority inspections.
• Maintain thorough knowledge of CAPA systems and apply GMP requirements effectively.