Manufacturing and Supply
Where the
miracles of
science are made
a reality for patients

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.  

Pursue Progress. Discover Extraordinary.

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

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