JobdescriptionLocation: Bulle, SwitzerlandActivity rate: 100%Contract: temporary contractStart date: 02.06.2025End date: 31.12.2025UCB, one of Switzerland's Best Employers, is an internationally active biopharmaceutical company specialising in the therapeutic areas of neurological disorders and immunology. The Bulle site is home to the company's Swiss sales subsidiary and primarily a biotechnological and chemical production platform for the manufacture and distribution of pharmaceutical specialities for the treatment of allergy, epilepsy and autoimmune diseases.We are looking for a Devices Development Quality Lead to drive QA activities for Medical Devices and Combination Products. In this global role, you will ensure compliance with regulations and standards while collaborating with key vendors and internal teams. This position reports to the Head of Pipeline Drug Delivery Devices Quality.Your key responsibilities:Provide expert QA support for vendors in design, development, testing, and manufacturing of Medical Devices and Combination ProductsEnsure compliance with MDR, ISO, and GMP/cGMP requirements throughout development and commercializationOversee Design & Development activities, including Validation/Verification, risk management, and regulatory submissionsReview and approve key documentation: design control files, Technical Documentation Files, DHF, and Verification & Validation protocolsManage vendor quality, ensuring alignment with UCB in design, technology transfer, and quality systemsConduct assessments/audits, negotiate Quality Agreements, and monitor vendor performanceApprove or block device release based on quality and compliance criteriaLead investigations for deviations and change management, track CAPA events, and oversee change controlsAct as QA liaison for external vendors, supporting regulatory inspections and collaborating with Corporate QA and Technical OperationsEnsure audit readiness, maintain compliance with ISO, MDR, and GMP, and support quality system improvementsTrack key performance indicators and contribute to Management Review and Design ReviewsQualifikationenWhat will make you successful:Master's degree in management of Devices / Combination products or related diploma3 to 6 years of experience in design control within the Medical Devices industry; combination products experience is a plusStrong knowledge of ISO 13485, 21 CFR Part 820, MDR, and ISO 14971Root cause analysis and risk management skills, with the ability to independently analyze data, assess risks, and propose corrective actionsProblem-solving and innovative thinking, demonstrating initiative and creativity to develop solutions and help others find practical resolutionsCoaching and mentoring abilities, guiding teams through effective problem-solving to ensure optimal outcomesStrong leadership and teamwork skills, able to motivate, influence, and collaborate in cross-functional and cross-cultural environmentsExcellent communication abilities, confident in presenting, providing feedback, and engaging with internal and external stakeholdersFluent in English (mandatory); French is a plusUCB is committed to fostering a diverse, inclusive, and equitable workplace where everyone's talents and perspectives are valued and respected.Laetitia Stirer