UCB, 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 Products
Ensure compliance with MDR, ISO, and GMP/cGMP requirements throughout development and commercialization
Oversee Design & Development activities, including Validation/Verification, risk management, and regulatory submissions
Review and approve key documentation: design control files, Technical Documentation Files, DHF, and Verification & Validation protocols
Manage vendor quality, ensuring alignment with UCB in design, technology transfer, and quality systems
Conduct assessments/audits, negotiate Quality Agreements, and monitor vendor performance
Approve or block device release based on quality and compliance criteria
Lead investigations for deviations and change management, track CAPA events, and oversee change controls
Act as QA liaison for external vendors, supporting regulatory inspections and collaborating with Corporate QA and Technical Operations
Ensure audit readiness, maintain compliance with ISO, MDR, and GMP, and support quality system improvements
Track key performance indicators and contribute to Management Review and Design Reviews
Location: Bulle, Switzerland
Activity rate: 100%
Contract: temporary contract
Start date: 02.06.2025
End date: 31.12.2025
UCB, 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 Products
Ensure compliance with MDR, ISO, and GMP/cGMP requirements throughout development and commercialization
Oversee Design & Development activities, including Validation/Verification, risk management, and regulatory submissions
Review and approve key documentation: design control files, Technical Documentation Files, DHF, and Verification & Validation protocols
Manage vendor quality, ensuring alignment with UCB in design, technology transfer, and quality systems
Conduct assessments/audits, negotiate Quality Agreements, and monitor vendor performance
Approve or block device release based on quality and compliance criteria
Lead investigations for deviations and change management, track CAPA events, and oversee change controls
Act as QA liaison for external vendors, supporting regulatory inspections and collaborating with Corporate QA and Technical Operations
Ensure audit readiness, maintain compliance with ISO, MDR, and GMP, and support quality system improvements
Track key performance indicators and contribute to Management Review and Design Reviews
qualifications
What will make you successful:
Master's degree in management of Devices / Combination products or related diploma
3 to 6 years of experience in design control within the Medical Devices industry; combination products experience is a plus
Strong knowledge of ISO 13485, 21 CFR Part 820, MDR, and ISO 14971
Root cause analysis and risk management skills, with the ability to independently analyze data, assess risks, and propose corrective actions
Problem-solving and innovative thinking, demonstrating initiative and creativity to develop solutions and help others find practical resolutions
Coaching and mentoring abilities, guiding teams through effective problem-solving to ensure optimal outcomes
Strong leadership and teamwork skills, able to motivate, influence, and collaborate in cross-functional and cross-cultural environments
Excellent communication abilities, confident in presenting, providing feedback, and engaging with internal and external stakeholders
Fluent in English (mandatory); French is a plus
UCB is committed to fostering a diverse, inclusive, and equitable workplace where everyone's talents and perspectives are valued and respected.
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1630 Bulle, Fribourg
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Laetitia Stirer
Randstad UCB Bulle
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