Job Title: Head – Quality Assurance
Company: Sanofi
Location: Mumbai, India
Work Mode: 40% Remote | 20% Travel Expected
Job Type: Permanent
Team Overview:
External Manufacturing India (EM India) manages Sanofi products manufactured at CMOs across India and the Asia-Pacific region. The team oversees solid orals, semi-solid, liquids, and parenteral dosage forms, handling manufacturing, quality, regulatory, and supply operations.
Purpose of Role:
To implement and monitor quality systems at Sanofi’s external manufacturing sites in compliance with cGMP and Sanofi’s global quality documents, ensuring that products delivered to the market meet the required standards.
Mission:
Lead and manage the Quality strategy across the External Manufacturing network, ensuring compliance with global quality standards and applicable regulations.
Key Responsibilities:
1. Operational Management of CMOs
Lead QA operations team to ensure cGMP compliance at CMOs.
Ensure compliance with Sanofi directives, GMP, and regulatory standards.
Oversee timely release and validation of pharmaceutical products.
Supervise change management, deviations, OOS, stability, and market complaint systems.
Ensure Quality Agreement compliance at CMOs.
2. Quality Management System (QMS)
Ensure QMS compliance with global Sanofi procedures.
Drive CAPAs, investigations, and continuous improvement initiatives.
Manage quality escalations and proactive risk assessments.
Track and improve KPIs across external manufacturing.
3. CMO Quality Reviews
Lead site quality reviews and develop quality improvement plans.
Ensure implementation of action items from reviews and audits.
4. Quality Agreements
Maintain and periodically review quality agreements with CMOs and suppliers.
Ensure clarity on cGMP responsibilities between Sanofi and partners.
5. Regulatory Compliance and Audit Readiness
Ensure audit readiness for local and export markets.
Conduct on-site quality reviews and compliance assessments.
Implement findings from audits promptly.
6. Risk Assessments
Conduct risk assessments and develop CAPAs.
Perform CMO risk ranking and implement improvement plans.
7. Additional Responsibilities
Assess and implement global procedures.
Monitor KPIs and lead due diligence for new product launches.
Oversee technology transfers and continuous improvement projects.
Conduct post-audit assessments.
Ensure artwork compliance and cross-functional alignment.
Qualifications & Experience:
Education: B.Pharm / M.Pharm / MSc / PhD in Life Sciences
Experience:
12+ years in Quality Assurance
2–4 years of team handling experience
Languages: English, Hindi
Key Skills:
Strong expertise in QA & QC
Team leadership and stakeholder management
GMP and regulatory compliance
Analytical skills and process improvements
Cross-functional collaboration
Handling various pharmaceutical dosage forms
Managerial courage for decision-making
Diversity & Inclusion Statement:
Sanofi is committed to creating a diverse and inclusive work environment. They provide equal opportunities irrespective of race, religion, gender, or any other protected characteristic.
Job Scam Notice:
Sanofi never requests payments or financial/personal information during recruitment. Verify legitimate openings via Sanofi Careers.
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