Can be based from Cambridge, UK, Montpellier or Vitry-Sur-Siene France or Frankfurt, Germany The role is with Kymab, a Sanofi company About the Opportunity A fantastic opportunity has arisen with the quality group at Sanofi! The purpose of this position is to provide quality direction and support to Sanofi R&D project(s) by serving as the quality and compliance lead in the project teams from late stage development up to and including launch (+ 1 year). About Kymab Kymab, a Sanofi company, is a biopharmaceutical organization focused on developing novel human antibody-based therapies in a broad range of indications across immune-oncology, haematology, infectious and immune diseases. The Company generates its product candidates using its proprietary, integrated platforms collectively called IntelliSelect®. Kymab’s platforms have been designed to maximize the diversity of human antibodies produced in response to immunization with antigens. Selecting from a broad diversity of fully human antibodies allows for the identification of antibodies with optimal drug-like properties. Our mission is to deliver modern medicines on unique platforms, bring hope to patients with high unmet medical needs, and to be an effective global partner in ameliorating global disease. Key Responsibilities for position About growing with us In this role you will…. Research & Development (R&D) & Industrial Affairs (IA) quality rep in the project teams Set up and lead quality sub-team to coordinate and optimize cross sites and cross functions quality activities within R&D and IA, and external partners (as required) Ensure Sanofi quality standards and current regulatory requirements are integrated into the project development plan, provides support/expertise for implementation and ensures high quality deliverables Prevent and alert on time on the quality issues and risks Follow-up quality deliverables, monitors progress of notified project deviations and change controls with their justification and associated action plan; as well as project risk management activities Lead all actions for Pre-approval Inspection (PAI) and pre-Launch Quality readiness, and contribute to regulatory documents/registration dossier and launch preparation Review &/or approve key Chemistry, Manufacturing & Controls (CMC) documents such as technology transfer & validation documents and CMC parts of the dossier Manage the transition of a project to a commercial product by acting as the interface between the CMC project teams and IA quality functions and sites Manage communication actions on his/her projects (as applicable): Quality Meetings, Pre-Approval Inspection Management Group (PMG), Launch Quality Readiness meetings, IA Product Quality Review (participation), project reviews, CMC board meetings, IA steering committees, CMC tracking and reporting tools etc Other actions not specific to the project management: Manage Quality Notifications and other investigations Conduct external audits, self-inspections, due diligences Back-up for Batch Release activities (as needed) Scope of Responsibility The role holder liaises with and between all R&D & IA quality representative involved in the project; as well as makes the link with R&D Sites Quality Operations (SQO) Management and external partners (as required) The incumbent plays a key role in leading and coordinating R&D & IA Quality activities according to CMC development and launch readiness project strategy and objectives Sanofi R&D Sites, interactions with Industrial Affairs, CMC, Global Quality, Clinical, Alliance Management, Regulatory, Business Development, Legal, Project Teams, external partners (as required) Competencies/ Requirements for position About you Qualifications/ Education & work experience In-depth knowledge of quality regulations and guidelines applicable to R&D pharmaceutical activities Excellent interpersonal, communication and facilitation skills Must have thorough knowledge of development processes applied to Sanofi R&D projects and be experienced in CMC sub-teams Must be familiar with all processes associated with batch releases (review of batch records, Certificate of Analyses (COA's), Certificates of Conformance (COC's), Corrective and Preventitive Actions (CAPAs), deviations, change controls, etc), quality agreements and audits and must be fully conversant in at least one quality areas (e.g. GMP) Knowledge of biotechnology manufacturing and aseptic processing preferred Knowledge of medical and drug devices A good understanding of all areas of the Sanofi businesses beyond pharmaceuticals (including veterinary, vaccines and biologics) is a distinct advantage Education: Ph.D., M.S., B.S. or other university or engineering degrees in one of the areas of pharmaceutical drug development (e.g. Pharmacy, Chemistry, Biochemistry, Biotechnology or closely related discipline) Professional Experience: A minimum of 4 years in the Pharmaceutical Industry with at least 4 in a quality environment: Ph.D. plus 4 years in a quality environment. M.S./MBA plus 6 years industrial experience with at least 4 in a quality environment. B.S. plus 10 years in a pharmaceutical or R&D environment with at least 6 being in a Quality related field. Core Competencies: GxP (at least one core) Project management (experience in working in project team and in complex environment, dealing with leading international and/or multi-cultural teams) Research & Development activities and processes (in particular in the CMC related field) Risk Management methodology Strong problem-solving skills Strong communications skills Proactive and innovative mindset Change agent English: Fluent professional practice Note: Candidate may also serve role as a Qualified Person for organization depending on qualifications and background Inspire your Journey: what Kymab can offer you: A close knit, family feel work environment, in which you can develop your talent and realize ideas and innovations within a competent team An attractive, market-oriented salary aligned with your qualifications and including social benefits An individual and well-structured introduction and training when you onboard You can create your own career path within Kymab. Your professional and personal development will be supported purposefully As a Sanofi company you will have the opportunity to constantly grow, as Sanofi provides international career paths as well Link to Career page https://www.kymab.com/careers/ Own your future. Make your move! Pursue Progress. Discover Extraordinary. Visas for those who do not already have the right to work in the UK will be considered on a case by case basis according to business needs and resources. #LI-EUR At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.