Role Summary

The Third Party Audits Manager at Sanofi is responsible for conducting quality audits of suppliers in Asia to ensure compliance with regulatory and quality standards. The role involves managing audit programs, supporting regulatory inspections, and facilitating communication between third parties and Sanofi sites.

Job Description

The M&S Quality Services, Third Party Audits Manager at the KL Hub is responsible for performing GxP Quality Audits of various Third Parties including Pharmaceutical Starting Materials, APIs, Excipients, and Drug Product Manufacturers among others in India and Asian countries. This role involves providing independent assessments of supplier quality, ensuring compliance with regulatory and quality requirements, managing audit programs, and facilitating communication between third parties and Sanofi sites. The manager also contributes to qualification of new auditors, supports regulatory inspections, proposes improvements, and ensures adherence to corporate and divisional quality standards.

Job Requirements

Minimum 7 years' experience in Quality and/or Regulatory function in a reputable Pharmaceutical or Biopharmaceutical company including performing Third Party Audits in categories such as API, Excipients, Chemicals, Raw Materials, and Drug Product Manufacturers.

Thorough knowledge of cGMPs and Code of Federal Regulations in drugs and biologics.

Knowledgeable in pharmaceutical industry quality functions.

Experience conducting on-site audits, inspections, and handling regulatory/health authority inspections and audits.

Thorough knowledge of CAPA systems with relevant experience.

Experience in application of GMP requirements.

Preferred experience managing third party manufacturers and contract manufacturer organizations.

Working experience on manufacturing sites is an advantage.

Possession of GxP Auditor certifications from reputed certifying agencies is preferred.

Bachelor’s Degree in Science, Pharmacy, Biotechnology, Microbiology or a related field.

Strong business partnering and communication skills.

Capability for internal and external networking.

Negotiation and influential skills.

Problem-solving and decision-making abilities.

Organizational skills and multitasking in stressful environments.

Team player with excellent interpersonal and conflict management skills.

Ability to adapt quickly to unexpected situations and reorganize priorities.

Technical skills include operational experience in Pharma/Biotech/Medical Device and Vaccines manufacturing, analytical and quality assurance expertise, auditing skills, training capabilities, and readiness to travel.

M&S Quality Services, Third Party Audits Manager – Sanofi-Aventis

Sanofi-Aventis

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