Jobdescription
Location: Bulle,Switzerland
Activity rate:100%
Contract: temporarycontract
Start date:02.06.2025
End date:31.12.2025
UCB, one ofSwitzerland's Best Employers, is an internationally activebiopharmaceutical company specialising in the therapeutic areas ofneurological disorders and immunology. The Bulle site is home tothe company's Swiss sales subsidiary and primarily abiotechnological and chemical production platform for themanufacture and distribution of pharmaceutical specialities for thetreatment of allergy, epilepsy and autoimmunediseases.
We are looking fora Devices Development Quality Lead to drive QA activities forMedical Devices and Combination Products. In this global role, youwill ensure compliance with regulations and standards whilecollaborating with key vendors and internal teams. This positionreports to the Head of Pipeline Drug Delivery DevicesQuality.
Your keyresponsibilities:
* Provide expert QAsupport for vendors in design, development, testing, andmanufacturing of Medical Devices and CombinationProducts
* Ensure compliance with MDR, ISO, andGMP/cGMP requirements throughout development andcommercialization
* Oversee Design &Development activities, including Validation/Verification, riskmanagement, and regulatory submissions
* Reviewand approve key documentation: design control files, TechnicalDocumentation Files, DHF, and Verification & Validationprotocols
* Manage vendor quality, ensuringalignment with UCB in design, technology transfer, and qualitysystems
* Conduct assessments/audits, negotiateQuality Agreements, and monitor vendorperformance
* Approve or block device releasebased on quality and compliance criteria
* Leadinvestigations for deviations and change management, track CAPAevents, and oversee change controls
* Act as QAliaison for external vendors, supporting regulatory inspections andcollaborating with Corporate QA and TechnicalOperations
* Ensure audit readiness, maintaincompliance with ISO, MDR, and GMP, and support quality systemimprovements
* Track key performance indicatorsand contribute to Management Review and DesignReviews
Qualifikationen
What will make yousuccessful:
* Master's degree inmanagement of Devices / Combination products or relateddiploma
* 3 to 6 years of experience in designcontrol within the Medical Devices industry; combination productsexperience is a plus
* Strong knowledge of ISO13485, 21 CFR Part 820, MDR, and ISO 14971
* Rootcause analysis and risk management skills, with the ability toindependently analyze data, assess risks, and propose correctiveactions
* Problem-solving and innovativethinking, demonstrating initiative and creativity to developsolutions and help others find practicalresolutions
* Coaching and mentoring abilities,guiding teams through effective problem-solving to ensure optimaloutcomes
* Strong leadership and teamwork skills,able to motivate, influence, and collaborate in cross-functionaland cross-cultural environments
* Excellentcommunication abilities, confident in presenting, providingfeedback, and engaging with internal and externalstakeholders
* Fluent in English (mandatory);French is a plus
UCB is committed to fostering a diverse,inclusive, and equitable workplace where everyone's talents andperspectives are valued and respected.