Senior Quality Assurance Specialist (External manufacturing)

Job title: Senior Quality Assurance Specialist (External manufacturing)

Location: Cairo Site

Grade: L2-1

Hiring Manager: Mohamed Kabeel - Quality Assurance External Manufacturing Section Head

About Sanofi:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Job Purpose:

Oversee and ensure quality compliance of external manufacturing partners (CMOs) through quality agreement management, audits, product transfers, CAPA follow-up, and technical complaint resolution, ensuring adherence to cGMP standards and regulatory requirements.

Main responsibilities:

1. Responsible for External Manufacturing activities:

• Preparation of Quality agreements with manufacturing subcontractors performing activities on behalf of SANOFI and follow up of its approval.

• Following up CAPA implementation of external audits.

• Frequent visits to subcontractors to follow up the process and to ensure compliance to cGMP, SANOFI requirements when applicable and with local regulations.

• Review of CMOs quality documents including validation documents, deviation reports, change control requests, APRs, products QSMPs within specified timelines.

• Conduct gap analysis for CMOs management global guidelines.

• Keep QTP module updated with CMOs related information.

• Perform final release of toll out products within the specified timelines.

• Preparation of external manufacturing quality Monthly report.

• Conduct annual quality review for the CMOs.

• Follow up on CAPA implementation resulting from external audits.

• Ensure proper change control implementation across external manufacturing operations.

• Support regulatory inspections at external manufacturing sites.

• Maintain comprehensive quality records and documentation systems.

• Ensure compliance of third parties with Sanofi standards and local regulatory requirements.

2. Localization & Product Transfer Projects:

• Management of the project from quality aspects (e.g. Clexane toll manufacturing).

• Lead the quality compliance activities during the project phase with the toll manufacturer.

• Lead the qualification & validation activities of the project.

• Act as focal point the technical topics during the transfer activities between SANOFI MSAT & local toll manufacturer.

• Review of CMOs quality documents including validation documents, deviation reports, change control requests, APRs, products QSMPs within specified timelines.

• Participate in externalization projects to CMOs regarding all quality activities.

3. Management of Product Technical Complaints:

• Participate in investigating, root cause identification and action plan follow up for all Sanofi Customer Complaints at CMO level.

• Communication and follow up customer complaint investigation related for toll out products at COMs level.

4. Participate in Quality Risk Management:

• Participate in identifying, analyzing, evaluating, controlling, communicating, and reviewing potential or identified risks related to quality and GxP compliance in alignment with global quality documents.

• Work as risk assessments facilitator for the assigned risks.

5. Cross-Functional Collaboration & Continuous Improvement

• Partner with procurement, regulatory affairs, supply chain, and business development teams.

• Support Global Quality Audits at external manufacturing sites.

• Provide technical expertise to project teams and senior management.

• Identify and implement best practices and process improvements to reduce quality and supply risks.

6. HSE Responsibilities:

• Responsible for applying the HSE related requirements for the company in all related working procedures.

• Ensures HSE approval on any SOP that requires certain HSE precautions.

• Ensures HSE approval on any change.

• Follow the laboratory safety procedures

• Commitment to the appropriate PPE use.

• Follow the approved HSE policy and requirements.

• Following the statutory legislation concerning Health, Safety and environmental law.

• Hydrocarbons/ hazardous substance & waste segregation in accordance with approved waste management system.

7. Others:

• Perform other duties as assigned.

• Respect the company’s values, code of ethics and social charter.

• Respect of personal data protection charter.

Requirements/Qualifications:

•Education: Bachelor's degree in pharmacy.

. Experience:

• 5+ years’ experience in related positions (QA, QC and Production)

• 3+ years’ experience in external manufacturing.

• Experience with sterile manufacturing is preferable.

• Experience in QA Auditing, Validation and Qualification is preferable.

Technical Skills:

• Ability to interact, co-ordinate and manage different stakeholders either within SANOFI (External manufacturing global, MSAT department, Project management) or outside SANOFI as CMOs and external suppliers.
• Ability to co-ordinate several inter-departmental activities.
• Good Manufacturing Practices (GMP) & Good Documentation Practices (GDP), SANOFI guidelines & standards.
• Think Strategically, Lead Teams, Develop People, Make Decision.
• Act in the interest of our patients and customers
• Good communication and Presentation skills.
• Problem solving skills and People management.
• Good command of MS Word, Excel & Power Point.
• Fluent in English and Arabic languages, both written and spoken

Why choose us?

• Help shape the future of care for chronic and complex conditions like diabetes and cardiovascular disease - and make a real impact at scale, with medicines that reach over 100 million people each year.

• Lead a high-impact portfolio with bold ambitions and significant upcoming launches.

• Drive meaningful change in a streamlined, AI-powered organization that values smart, modern ways of working.

• Expand your leadership impact through cross-functional collaboration and international career paths.