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

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 & Perform Quality Audits of Third Parties, upon request according to annual audit program in place.

• Provide an independent assessment of Third Parties quality in place with regards to material compliance, as well as regulatory and quality requirements.  

• Identify gaps and area of improvements, 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 solution to improve Third Parties Quality Audit process as & when required. 

• Participate to Quality Documentation update 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.  

• Responsible for compliance with Corporate and Divisional QA policies, procedures, standards, and specifications as well as country specific regulations depending on the TPM/CMO location and markets. 

• Ensure compliance to Corporate and Divisional QA requirements and identify and / or resolve Quality gaps and / 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. 

• Identify and propose process and procedure improvement proposals.  

• Manage supplier audits, ensuring cGMP and SOP alignment.  

• Track market developments, regulatory changes.  

• Contribute to team effectiveness, identify risks, formulate improvements.  

• Manage work processes efficiently, respect laws.  

• Follow up on CAPA’s.  

• Proactively monitor FDA, EMA requirements, share knowledge.  

• Coach and direct the team, conduct evaluation interviews, and assess training needs.  

• Provide an assessment of supplier’s quality in place with regards to material compliance, as well as regulatory of CAPA for Third Party sites  

• Being a local quality contact between the Suppliers, Global Quality Suppliers & IA sites to facilitate exchange of quality information  

• Support audits lead by other auditors when specific expertise is needed (e.g. for cause audit with user sites representatives, highly sophisticated topic)  

• Organize day to day agenda according to workload defined by the group. Establish 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 reputed Pharmaceutical / Biopharmaceutical Company with experience in performing Third Party Audits in various categories including API, Excipients, Chemicals, Raw Materials, Drug Product Manufacturers, Service Providers, etc. 

• Thorough knowledge of cGMPs, Code of Federal Regulations in drugs and biologics  

• Should be 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 and experience is desirable  

• Thorough knowledge of and experience in application of GMP requirements  

• Experience managing third party manufacturers and/or contract manufacturer organization is preferred.  

• Experience of working on manufacturing sites is an added advantage.

• Thorough knowledge of CAPA systems is required and experience is desirable  

• Thorough knowledge of and experience in application of 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 / 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 & challenge data from different sources 

• Excellent ability to adapt quickly to unexpected situations and reorganize priorities on the spot and adapt the audit conduct according to findings 

• Excellent listening skills, interpersonal skills, ability to manage conflict and step back when required     

Technical skills

• Operational experience of Pharma/Biotech/Medical Device and Vaccines manufacturing (Pharma/Bio tech/Medical Device etc.) 

• Analytical & Quality Assurance 

• Auditing Skills 

• Training 

• Ready to travel