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Manufacturing and Supply

Manufacturing and Supply
Where the
miracles of
science
are made
a reality
for patients

Head- Quality, APAC

Mumbai, India
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At a glance

Our teams produce and deliver over 4 billion units of medicines and vaccines every year, ensuring every breakthrough gets to the people who need it most.
Our state-of-the-art facilities, AI-powered smart factories, and cutting-edge automation are redefining what’s possible: ensuring treatments reach patients faster, safer, and more sustainably than ever before. This is where your skills, ambition, and passion can shape the future of healthcare.

JOB DESCRIPTION

Purpose:

  • Define, establish, and monitor quality management systems at EM&S APAC as per cGMP and Sanofi Global Quality policies to ensure the quality of products DP and DS.

  • To ensure regulatory compliance for domestic and export Drug products and API manufactured by External Manufacturing sites of Sanofi.

  • Collaborate with Quality Operations Cluster Head Quality Operations for rolling-out best practices and governance for CMO Quality Management within the EM&S APAC Quality network, ensuring quality oversight.

·Lead and coordinate quality and compliance of transversal projects for the EM&S APAC.

·Ensuring the renewal, registration, and maintenance of product dossiers & regulatory status for export and local markets for drug products and Drug substances.

Key Areas:

  • Quality and Compliance:

Quality management system:

Define, Implement & Maintain Quality management Systems for EM&S APAC products.

Ensure the compliance of the EM&S APAC quality system to the GOPs.

Ensure that local regulatory requirements and specificities are managed in alignment with the Global quality roadmap.

Oversight of the CMOs and other third parties managed by EM&s India

Perform risk ranking for CMO’s as per the Sanofi Directive and define the mitigation plan associated for medium and high risk CMO

Escalate any Quality issues as per the Global procedures.

Identify proactively any risk related to the CMO compliance to regulations and QTA and to EM&S APAC activities and define the mitigation plan to address these risks

Closely monitor CMO performance assessing KPIs, audit outcomes, responsiveness and other quality indicators

Quality agreement:

Establish Quality agreement between Sanofi and CMO’s: Facilitate negotiations and ensure valid QAg in place and updated whenever there is a change in relevant sections of QAg.

Technology Transfer:

Ensure smooth manufacturing/analytical technology transfer through close working with transferring site and receiving site

Ensure timely approval activities related to review and approval of transfer protocol, assessment of site laboratory readiness, sharing of methods, standards, test samples etc. as applicable.

Release of product:

Ensure timely approval of the process validation document for compliance and ensure that commercial batches are released in compliance with specifications.

Audit Management & Periodic Quality Risk Assessment:

Perform a Quality Risk assessment as necessary when the audit resulted with critical observation

Follow-up the implementation of the CMO audit CAPAs

Deviation / Investigation Management:

To achieve closure of the investigations within timeline defined by ensuring regulatory, quality compliance and put CAPA in place. To evaluate risk and escalate as per Sanofi GOP and perform assessment and CAPA.

Supplier Exit or Change of Supply:

Ensure the QA aspects (for example Stability, APR/PQR management etc.) associated with withdrawal or termination of a CMO.

  • Regulatory and compliance

Product Dossier Management for Export Products for Drug Product & Drug substance

Ensuring the renewal of product dossiers of DP & DS in timely manner.

Ensure to implement and follow GRA processes for all export product dossier management.

Regulatory Compliance:

Ensure that Maintaining the Regulatory status at External Manufacturing sites – preparation of applications – to procure new manufacturing licenses / additional products / surrender of license.

Ensure that the critical regulatory queries for local and export markets responded on timely manner.

Regulatory Authorities Inspection:

Ensuring timely completion of the compliance to the local and export regulatory audits of the contract manufacturing sites.

Act as SME submission of Finished Product Samples/ working standards to Reg. Authorities when asked for Follow-up and replies to complaints received.

  • Projects

Support to Business development projects. Participate and support EM&S/global entities for Selection and Approval of CMO Or Due diligences (for acquisition of new products)

  • Management of Team

Ensure adequately staffed quality unit, define individual roles and responsibilities, Provide technical support to the sites and quality agents to resolve issues related to quality.

Identify key associates and their training / developmental needs, organize to provide requisite training and monitor their development to ensure that they are developed for taking up higher responsibilities.

  • Artwork Management

To ensure the compliance of artwork Sanofi global guidelines and the general requirements as per Sanofi approved standards and SOP.

  • Deputation of responsibility

In absence the responsibility of Operation topics is delegated to Head QA and regulatory topics are delegated to Regulatory Managers.

Pre-requisites:

Knowledge, Skills & Competencies:

Sound Knowledge on Current GMP requirements of local and various international regulatory agencies, Drugs and Cosmetics Act and Rules, Pharmacopoeias, and ICH guidelines.

Exposure to regulated, semi regulated markets and experience of handling regulatory audits.

Skills for Effective communication, networking, interpersonal relations, assertiveness, and leadership.

Qualifications

B.Pharm/ M.Pharm  / Ph.D/ MS/ MSc

15 to 20 years total experience in the Pharmaceutical Industry out of which at least 10 to 15 years should be in Quality Function and rest in one more department like manufacturing or formulation department.

Minimum 4-5 years’ experience in senior leadership role

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As you conduct your job search, please beware of the possibility that scammers may post fraudulent job openings or send fraudulent communications (email, SMS, WhatsApp or Messenger messages pretending to be from Sanofi) regarding potential job postings or offers in an attempt to encourage the job seeker to disclose financial or personal information. We do not make any payments to or ask candidates for any fees as part of the application process. In most cases you can expect to hear directly from a member of our recruiting team with a legitimate @sanofi.com email address, but you may receive communications from one of our recruiting partners as well. Consequently, you should always conduct research to ensure a posting and/or offer is legitimate and you should never provide personal or financial information unless you are certain that the request is legitimate. If you are concerned that an offer of employment with Sanofi might be a scam, please verify by searching for the posting on the Careers webpage

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Pursue Progress. Discover Extraordinary.

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

Watch 'One day at Sanofi' and check out our Diversity Equity and Inclusion initiatives at sanofi.com

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Why work with us

  • We’re problem-solvers and pioneers. United by the belief that everyone deserves a healthier future. We create best-in-class vaccines that prevent disease and protect lives.

  • Innovation drives us. From AI and mRNA to next-gen science, we push the boundaries to deliver first- and best-in-class vaccines for infectious diseases worldwide.

  • Growth happens here. With bold investments in R&D and world-class facilities, Sanofians across the entire vaccine lifecycle are shaping the future of global health.

  • We do what’s right. Sustainability and DE&I drive our positive global impact—because the diverse communities Sanofians represent are the patients we serve.

All-in on diversity

At Sanofi, diverse perspectives fuel the best solutions for patients. Hear from Monique Vessey, our Supply Chain Transformation Leader, on how her background shapes her approach to delivering life-changing medicines.

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"Manufacturing and Supply is the bridge between the science that happens in research laboratories and the people and communities we serve."

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Executive Vice President of Manufacturing and Supply

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