Senior Quality Assurance Specialist Sterile

Job title: Senior Sterile Quality Assurance Specialist (External manufacturing)

Location: Cairo Site

Grade: L2-1

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.

About the job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

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:

• 3 - 5 years’ experience in related positions as QA.
• Experience with Sterile manufacturing is a must.
• Experience in external manufacturing is preferred
• 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

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!