Quality Project Leader – Aseptic Process & Tech Transfer

About the role

The Quality Project Leader will ensure expertise in aseptic processes for sterile injectable products, supporting equipment design, qualification, validation and quality system implementation across insulin projects. The role works closely with end‑users and Sanofi project teams to drive successful technology transfer and startup.

Key responsibilities

• Coordinate Quality Assurance and Quality Control activities for insulin projects, ensuring compliance with Sanofi and local regulatory requirements.
• Manage project‑related quality systems including documentation, deviations, CAPA, change control, training, qualification and third‑party management.
• Provide quality support for all technology transfer deliverables, reviewing validation protocols, risk assessments, method transfers and qualification reports.
• Monitor and close quality events, inspections and audits using a pull‑mode approach.
• Participate in engineering studies, URS development, equipment qualification and QC laboratory protocol definition.
• Maintain supplier and service‑provider databases, establish specification sheets and ensure readiness for regulatory inspections.
• Track quality KPIs, support audit reporting and contribute to the establishment of the project quality system.

Required profile

• Proven experience in aseptic processing for sterile injectable products.
• Strong knowledge of GMP (Annex 1) and pharmaceutical quality systems.
• Hands‑on experience with process, cleaning and transport validation.
• Ability to manage GxP documentation, deviations, CAPA and change control.
• Excellent collaboration skills with cross‑functional and external stakeholders.

Required skills

• Aseptic processing
• GMP (Annex 1) compliance
• Process validation
• Cleaning validation
• Transport validation
• Analytical method transfer
• GxP documentation management
• CAPA management
• Change control
• Risk assessment
• Equipment qualification
• Quality system implementation
• Regulatory inspection readiness