What are the responsibilities and job description for the Quality Project Leader position at sanofi?
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 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! We are an R&D driven, AI-powered biopharma company committed to improving people’s lives and creating compelling growth. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives. We want to build a healthier, more resilient world, and turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi Start a career that makes a difference. Reinvention is in our DNA. It’s what drove our evolution from a small French enterprise to one of the world’s leading biopharma companies. Whether it’s using AI to shorten drug-discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and communities. This is where you grow your career. We open the door for you to explore new opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people’s lives.