Title: Senior Director Clinical Quality AssuranceCompany: Ipsen Innovation (SAS)Job Description:Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care.We aim to make a sustainable difference by significantly improving patients’ health and quality of life and providing them with effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences and Rare Diseases.The patient is at the heart of everything we do, and we also care for our employees because they are the ambassadors who truly make the difference. We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions; leaders drawn by a purpose to make a direct impact through their work in people’s lives.The Senior Director Clinical Quality Assurance is a key member of the Global R&D Quality (GRDQ) leadership Team. In this role, you will be accountable for building and maintaining a fit for purpose Quality Assurance framework to enable Clinical and Non-Clinical activities are compliant with regulation and Ipsen standards. You will be a key stakeholder in Ipsen’s Quality activities and initiatives and drive the organisation with a continuous improvement approach.Your duties will also include:People management and DevelopmentResponsible for the direct line management of, and for ensuring the training, coaching, motivation, and development opportunities for employees within the Clinical and Non-clinical development unit. Assess the future workload demand, organize activities for the R&D QA in general and specifically Clinical and Non-Clinical teams and ensure the utilization of QA resources meets the R&D objectives.Supporting Clinical and Non-Clinical operational functionsProvide support to operational functions about regulatory requirements and quality outcomes. Lead R&D service providers qualification in collaboration with purchasing. Oversee day to day quality assurance support provided to operational team by the QA reps to ensure good clinical practices and relevant regulatory requirements are met and successful performance.Harmonization and optimization of operational processes and standardsDrive continuous improvement and implementation of new approaches and standards within GRDQ to support the new organisation. Participate in the development of global SOPs, policies, guidelines, or related tools via participation in working groups and collaboration with Transversal Services. Ensure consistent, timely and appropriate circulation of updated information and adequate reporting of implemented actions internally and externally.TrainingLiaise with process owners and trainers to ensure appropriate training material is generated and made available for clinical research activities. Contribute to training sessions as SME, by reviewing training materials or participating in presentations.Education, Knowledge & ExperienceMaster’s degree or higher in relevant scientific life science or other relevant scientific qualifications.10 years in international pharmaceutical quality assurance function, including at least 6-8 years’ experience in GxP Quality System, GCP clinical and / or GCP Quality operations related roles, (e.g.: GCP auditing, clinical trial management).Thorough knowledge and understanding of Global regulatory requirements, knowledge of GCPs, ICH requirements.Extensive knowledge of Research & development with experience in clinical operations, preferably global clinical trial management, global GCP inspections.Experience with FDA, EMA, MHRA or other regulatory inspections of sponsor, investigator sites, service providers.Ability to multi-task and to prioritize assignments in accordance with assigned project deadlines.Strong facilitation skills and team leadership: lead complex projects/assignments through discussions on complex and potentially controversial topics; bring consensus among diverse cross functional teams, interpersonal and communication skills (written and verbal).If you can point to an appropriate qualification as well as relevant experience, we would be delighted to engage with your application.#LI-HYBRIDDans le cadre de ses recrutements IPSEN s’engage au respect de l’égalité de traitement des candidats, indépendamment du sexe, de l’âge, de l'orientation sexuelle, de l'origine ethnique, de la couleur de la peau, de la nationalité, du handicap ou de l'appartenance à un syndicat.
