Job Title:
Head – Quality Assurance Operations
Company:
Sanofi
Location:
Mumbai, India
Date Posted:
March 13, 2025
Expiry Date:
April 14, 2025
Job Type:
Permanent
Work Arrangement:
40% Remote
20% Travel Expected
Team Overview:
External Manufacturing India (EM India) manages Sanofi products manufactured by CMOs (Contract Manufacturing Organizations) in India and the Asia-Pacific region, covering solid orals, semi-solids, liquids, and parenterals. The team handles operations related to manufacturing, quality, regulatory, and supply.
Purpose:
To implement and monitor Quality Systems at Sanofi’s external manufacturing sites, ensuring compliance with cGMP and Sanofi Global Quality Document Requirements, thereby guaranteeing the quality of market-delivered products.
Mission:
Lead and manage quality strategy within the External Manufacturing network, ensuring drug product manufacturing and distribution meet global quality standards and regulatory requirements.
Main Responsibilities:
Operational Management of CMOs
Lead QA operations and ensure cGMP compliance.
Oversee product release, validations, qualifications, deviations, OOS, complaints, and change management.
Guide QA Managers on evaluating and implementing CMO quality compliance.
Ensure adherence to Quality Agreements.
Quality Management System
Ensure compliance with Sanofi’s global QMS.
Manage CAPAs, quality investigations, APQR reviews, and quality escalations.
Identify risks and implement mitigation plans.
Oversee quality performance via KPIs.
CMO Quality Reviews
Execute Site Quality Reviews (SQR) and ensure timely action plan implementation.
Drive quality improvement initiatives at CMOs.
Quality Agreements
Maintain and periodically review Quality Agreements with CMOs/suppliers.
Define cGMP responsibilities and negotiate updates as needed.
Regulatory & Audit Compliance
Conduct on-site reviews and ensure audit readiness.
Ensure timely completion of corrective actions post regulatory audits.
Quality Risk Assessments
Identify potential quality risks and assign appropriate CAPAs.
Conduct CMO risk rankings and align improvement plans with EM India management.
Additional Responsibilities
Implement global procedures via impact assessments.
Monitor and act on KPIs.
Evaluate new product sites and ensure timely product launches.
Support tech transfers and continuous improvement projects.
Ensure accurate product artworks and cross-functional alignment across product lifecycle.
About You:
Education:
B.Pharm / M.Pharm / MSc / PhD in Life Sciences
Experience:
12+ years in Quality Assurance
2–4 years in team leadership
Technical Skills:
QA, QC, analysis, stakeholder management
Handling of multiple pharmaceutical dosage forms
Regulatory and audit preparedness
Soft Skills:
Effective communication
Team handling
Cross-functional collaboration
Decision-making courage
Languages:
English
Hindi
Scam Alert:
Sanofi never asks for payments or personal financial info during the hiring process. Always verify job offers via Sanofi Careers.
Diversity & Inclusion Statement:
Sanofi provides equal opportunities regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
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