M&S Quality Services, Third Party Audits Manager - KL Hub

Sanofi; Selangor; On-site; MYR 70,000 - 90,000; Full time

Job summary

A leading global life sciences company is seeking a Quality Auditor with a minimum of 7 years' experience in the pharmaceutical industry. This role involves conducting GxP quality audits of third-party suppliers and contractors across various Asian countries. The ideal candidate should have thorough knowledge of cGMPs and experience in managing quality compliance. This position offers opportunities for travel and engagement in a collaborative environment committed to improving healthcare access.

Qualifications

• Minimum 7 years’ experience in quality and/or regulatory function.
• Thorough knowledge of cGMPs and regulations.
• Experience managing third-party manufacturers preferred.

Responsibilities

• Organize, plan and perform quality audits of third parties.
• Provide independent assessments of quality compliance.
• Identify gaps and propose improvements.

Skills

Business partnering

Communication skills

Problem solving

Decision making

Negotiation and influential skills

Education

Bachelor’s Degree in Science, Pharmacy, Biotechnology or Microbiology

Job description

About the Job

Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare. More than 110,000 people in over 100 countries at Sanofi are dedicated to making a difference on patients’ daily life, wherever they live and enabling them to enjoy a healthier life.

As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health.

The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams in partnership with Business and Digital, and drive priority and transformative initiatives across M&S. The team members of Global M&S Services Hubs will act as partners in carrying out tasks and fulfilling responsibilities to support identified and established global quality processes from the hubs.

Purpose

To perform GxP Quality Audits of all Third Parties (Pharmaceuticals Starting Materials. APIs, Excipients, Packaging materials, Drug Product Manufacturers, Service Providers, Medical Devices, etc.) located in India and Asian countries, requested according to annual plan, on behalf of Sanofi entities.

Mission

• Provide an accurate, independent assessment of suppliers and contractors used by Sanofi sites.
• Ensure that Third Parties achieve, maintain and improve the expected level of quality.

Main responsibilities

• Organize, plan and perform quality audits of third parties, upon request according to annual audit program in place.
• Provide an independent assessment of third parties quality with regard to material compliance, regulatory and quality requirements.
• Identify gaps and areas of improvement, communicate results if needed and ensure the availability of CAPA for complete communication.
• Interface between the third parties and sites using them to facilitate follow‑up of improvements and exchange of quality information.
• Participate in qualification of new auditors in the hub, by performing audits with them and providing expertise regarding quality assessment of third parties.
• Support audits led by other auditors when specific expertise is needed (e.g. for cause audit with user site representative, highly sophisticated topics).
• Interact with Global Quality Third Parties Audit Management and Third Parties Quality Management colleagues for enhancement as & when required.
• Propose innovative solutions to improve third parties quality audit process as & when required.
• Participate in quality documentation updates as & when required.
• Provide QA and technical support to third party manufacturers (TPM) and contract manufacturer organizations (CMO), TPM/CMO operations, affiliates and other stakeholders.
• Ensure compliance with corporate and divisional QA policies, procedures, standards and specifications as well as country specific regulations depending on TPM/CMO location and markets.
• Identify and resolve quality gaps or issues relating to product design, manufacturing quality programs and product start‑ups at TPM’s and CMO’s.
• Support root cause analysis (RCA) investigations of quality events as required.
• Utilize understanding of QA systems and problem‑solving tools to provide alternative solutions to quality issues.
• Lead the quality compliance team ensuring cGMP compliance and inspection readiness.
• Manage supplier audit programs and follow up on regulatory audits.
• Oversee regulatory intelligence and contribute to quality risk management (GRT) on‑site.
• Manage supplier audits, ensuring cGMP and SOP alignment.
• Track market developments and regulatory changes.
• Contribute to team effectiveness, identify risks and formulate improvements.
• Manage work processes efficiently, respecting laws.
• Follow up on CAPAs.
• Proactively monitor FDA and EMA requirements, sharing knowledge.
• Coach and direct the team, conduct evaluation interviews and assess training needs.
• Organize day‑to‑day agenda according to workload defined by the group, establishing monthly reports and indicators for priority decisions.
• Conduct on‑site and remote audits of GxP and health‑regulated third‑party vendors to ensure compliance with regulations and company policies.
• Prioritize audit planning to meet audit, assessment and monitoring plans.
• Collaborate with stakeholders regionally for inspection preparedness.

About You

• Minimum 7 years’ experience in quality and/or regulatory function at a reputed pharmaceutical/biopharmaceutical company with experience in performing third‑party audits in categories including API, excipients, chemicals, raw materials, drug product manufacturers and service providers.
• Thorough knowledge of cGMPs, Code of Federal Regulations in drugs and biologics.
• Knowledgeable in quality functions of pharmaceutical industry.
• Experience in conducting on‑site audits, inspections and facing regulatory/health authority inspections/audits.
• Thorough knowledge of CAPA systems is required; experience is desirable.
• Experience in applying GMP requirements.
• Experience managing third‑party manufacturers and/or contract manufacturer organization is preferred.
• Experience of working on manufacturing sites is an added advantage.
• Preferred: GxP auditor certifications through reputed certifying agencies.

Education

• Bachelor’s Degree in Science, Pharmacy, Biotechnology or Microbiology preferred or any related field of studies.

Soft skills

• Business partnering
• Communication skills
• Internal and external networking capability
• Negotiation and influential skills
• Problem solving
• Decision making
• Organizational skills
• Team player
• Multitasking in stressful environment
• Ability to make realistic diagnosis, question the evidence and challenge data from different sources
• Excellent ability to adapt quickly to unexpected situations and reorganize priorities on the spot and adapt audit conduct according to findings
• Excellent listening skills, interpersonal skills, ability to manage conflict and step back when required

Technical skills

• Operational experience in pharma, biotech, medical device and vaccines manufacturing.
• Analytical and quality assurance.
• Auditing skills.
• Training.
• Ready to travel.

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity, Equity, and Inclusion actions at sanofi.com!