Job Description

Roles & Responsibilities

Job title: Senior Quality Assurance Specialist (External manufacturing) Location: Cairo Site Grade: L2-1 Hiring Manager: Mohamed Kabeel - Quality Assurance External Manufacturing Section Head

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.

Desired Candidate Profile

• 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