Job Title:
Head – Quality, APAC
📍 Location:
Mumbai, India
🏢 Department / Function:
External Manufacturing & Supply (EM&S) – APAC Quality
👤 Reporting to:
Cluster Head, Quality Operations
🕒 Employment Type:
Full-time | Permanent
✈️ Travel Requirement:
As per business needs
🗂️ Job Category:
Quality Assurance / Quality Management / Regulatory Compliance
1. Purpose of the Role
The Head – Quality, APAC is responsible for defining, implementing, and monitoring Quality Management Systems (QMS) for External Manufacturing & Supply (EM&S) APAC operations.
This role ensures compliance with cGMP, Sanofi Global Quality policies, and regional regulatory requirements to guarantee product quality (Drug Products and Drug Substances) across APAC markets.
The position involves strong leadership in governance, compliance, risk management, and cross-functional collaboration to maintain Sanofi’s global quality standards.
2. Key Responsibilities
A. Quality Management & Compliance
Define, implement, and maintain QMS for EM&S APAC in alignment with Sanofi Global Quality policies.
Ensure compliance with local regulatory requirements and integrate them into global quality frameworks.
Provide oversight of CMOs and third-party sites, ensuring continuous quality monitoring and compliance.
Conduct risk ranking of CMOs and define mitigation plans for medium and high-risk partners.
Escalate quality issues according to Sanofi’s global procedures.
B. Quality Agreements & Technology Transfer
Establish, negotiate, and maintain Quality Agreements (QAg) with CMOs.
Ensure timely updates when relevant quality sections change.
Oversee manufacturing and analytical technology transfers, ensuring readiness, documentation, and approvals.
C. Product Release & Validation
Ensure process validation documents are reviewed and approved.
Guarantee timely release of commercial batches in full compliance with specifications and cGMP.
D. Audits & Risk Assessments
Conduct Quality Risk Assessments (QRA) after audits with critical observations.
Track CAPA (Corrective and Preventive Actions) and ensure closure within timelines.
Monitor audit outcomes, KPIs, responsiveness, and quality indicators for continuous improvement.
E. Deviation & Investigation Management
Ensure timely closure of deviations and investigations.
Conduct root cause analysis and define CAPA to prevent recurrence.
Evaluate and escalate risks per Sanofi Global Operating Procedures (GOPs).
F. Regulatory Affairs & Compliance
Manage product dossier renewals and maintain regulatory status for Drug Products (DP) and Drug Substances (DS).
Coordinate with Global Regulatory Affairs (GRA) for dossier management and updates.
Ensure regulatory audits and inspections are completed on time and compliance maintained.
Act as Subject Matter Expert (SME) during inspections and respond to regulatory queries promptly.
G. Supplier & CMO Management
Oversee QA aspects during supplier exit or supply chain changes.
Manage stability programs, APR/PQR, and CMO compliance documentation.
Provide quality oversight for new CMO selection and due diligence processes.
H. People Leadership & Development
Build and lead an effective quality team for APAC operations.
Define individual roles, responsibilities, and performance goals.
Identify training and development needs; foster succession planning for future leadership roles.
I. Artwork Management
Ensure artwork complies with Sanofi Global Guidelines, standards, and SOPs.
Oversee accuracy and regulatory conformity in artwork changes.
J. Project Support
Support business development initiatives, including new product acquisition and technology transfer.
Collaborate with global and regional teams for project evaluations and approvals.
K. Deputation of Responsibility
In absence of the Head, QA operational topics are delegated to Head QA,
and regulatory topics to Regulatory Managers.
3. Qualifications & Experience
🎓 Education
B.Pharm / M.Pharm / Ph.D / M.S / M.Sc in Pharmaceutical Sciences or related discipline.
💼 Experience
15–20 years total experience in the pharmaceutical industry.
Minimum 10–15 years in Quality Management functions.
At least 4–5 years in senior leadership roles.
Exposure to regulated and semi-regulated markets.
Experience in handling regulatory audits (USFDA, EMA, WHO, etc.).
4. Skills, Knowledge & Competencies
Technical Knowledge
Comprehensive understanding of:
Current GMP standards
Drugs & Cosmetics Act and Rules
ICH Guidelines and Pharmacopoeial standards
Regulatory audit management
Leadership & Behavioral Competencies
Strong leadership, decision-making, and stakeholder management.
Excellent communication and interpersonal skills.
Assertiveness, cross-functional influence, and conflict resolution.
Proven ability to lead multicultural teams and drive quality culture.
5. Why Join Sanofi?
At Sanofi, our teams produce and deliver over 4 billion units of medicines and vaccines annually — ensuring every breakthrough reaches patients faster, safer, and more sustainably.
Join us in transforming pharmaceutical manufacturing through AI-powered smart factories, automation, and innovation.
Your expertise can redefine what’s possible in global healthcare.
6. Equal Opportunity Statement
Sanofi is committed to diversity, equity, and inclusion (DE&I).
We provide equal opportunities regardless of race, color, religion, sex, national origin, sexual orientation, age, disability, or gender identity.
🔗 Learn more at sanofi.com
7. Fraud Alert
Beware of fraudulent job offers. Sanofi does not request payment or personal financial information during recruitment.
Verify job postings through the official Sanofi Careers website.
Pursue Progress. Discover Extraordinary.
Join Sanofi and shape the future of healthcare — for the world, and for yourself.
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