Quality Project Leader

Mission Objective

• Ensure expertise in aseptic processes for sterile injectable products in the context of equipment design, qualification, process validation, cleaning validation, transport validation, analytical method transfer, and quality system implementation.
• Coordinate and manage Quality Assurance and Quality Control aspects of insulin projects in coordination with end-users and the Sanofi project teams.
• Ensure the implementation and follow-up of defined quality actions within their scope to support the startup of insulin projects.
• Apply the pull mode to ensure the closure of quality events, inspections and audits within the project scope.
• Contribute to the establishment of the quality system for insulin projects, in compliance with Sanofi quality requirements and local regulatory standards.
• Manage project-related quality systems (documentation management, deviations, CAPA, Change Control, training and qualification, third-party management, etc.).
• Provide quality support for all Technology Transfer deliverables, ensuring alignment with GMP expectations and project timelines.
• Participate in the review, approval, and tracking of tech transfer documents including validation protocols, risk assessments, method transfers, and qualification reports.

Principales Activities

• Support Quality Assurance procedures related to the project.
• Manage all GxP documentation linked to the project.
• Participate in the management of deviations, CAPAs, and Change Controls related to the project.
• Monitor the training plans and qualification of employees related to the project.
• Track quality KPIs associated with the project.
• Participate in audit reports and quality agreements with suppliers (materials and services) according to the need.
• Follow up of Analytical Method Transfers.
• Participate in engineering studies of insulin projects.
• Participate in the development and approval of URS, process equipment qualification protocols, and QC Laboratory protocols.
• Set up supplier and service provider databases relevant to the project.
• Coordinate with Sanofi SME to establish the specification sheets for products, raw materials, and packaging items.
• Ensure readiness for and participation in regulatory inspections.
• Take part in project briefings involving cross-functional stakeholders (end-users, Sanofi project teams).
• Support the implementation of the quality system for transferred processes in alignment with Sanofi and local GMP requirements.
• Contribute to the readiness and compliance of documentation and quality deliverables required for validation batches.
• Ensure that registration documents are drawn up.
• Collaborate with the Tech Transfer Leader to ensure that training related to GMP and quality systems is conducted and documented.
• Collaborate with the Tech Transfer Leader to ensure validation strategy preparation and implementation in collaboration with all project stakeholders.

Skills

• Mastery in aseptic processes for sterile injectable products.
• Familiar with Quality Systems and GMP Annex 1 (sterile medicinal products).
• Well knowledge with Analytical method transfer.
• Familiar with quality manuals; Validation Master Plans; URS; Quality Plans; IQ; Software OQ; OQ; Q-Reports; Validation Activity Master Reports; SIP/Sterilization validation; Media Fill; Environmental monitoring in sterile areas; CIP/cleaning validation; IQ/OQ/PQ.
• Knowledge of cleanroom operations, stability studies, filter validation in sterile environments, Quality Control, and handling of OOS/OOT.
• Strong organizational and prioritization skills.
• Strong analytical and synthesis mindset.
• Well-developed interpersonal and communication skills.
• Well-developed soft skills.
• English level: Advanced.

Required training / work experience:

• Degree in Pharmaceutical Engineering, Chemical Engineering, Biotechnology, or a related scientific field.
• Minimum of 3 years’ experience in a similar position in a sterile injectable product manufacturing unit.