Help us transform patients’ lives.
At UCB, we put our heart, soul and skills into making a difference for people living with chronic disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation. Will you join us in our pioneering adventure?
Headquartered in Brussels, Belgium, is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. UCB operates in approximately 40 countries, the company generated revenue of € 4.6 billion in 2018.
To strengthen our Medical Devices Team in Bulle, Switzerland (40 min from Lausanne & 20 min from Fribourg) , we are looking to fill the position of Medical Devices QA Lead for a period of 6 to 12 months.
About the role:
This position will provide support operational Quality Assurance activities at key design, development and manufacturing vendors (in the GMP & ISO environment) for development and commercial vendors and specific internal QA support/consultancy for all Medical Devices such as drug delivery devices but more specifically medical mobile apps (Software as medical Devices), sensors and potentially IVDs. This will be achieved through close partnering with QA management at vendors sites and collaboration with UCB Technical Operations and other UCB teams. This position will ensure compliance to Medical Devices regulations and GMP compliance of Combination Products from a quality, safety and efficacy point of view.
Provide expert advice, support and management for technical operational QA and general QA matters for specific vendors, on behalf of UCB, in design/development of medical devices (including medical mobile apps) and combination products ensuring application of ISO and GMP requirements.
Specifically focused on the following:
Oversee Design & Development activities, from Inputs definition through Design Transfer (including Validation/Verification activities).
Review and approve protocols and reports for Verification & Validation studies, technology transfers, stability studies, etc…
Ensure risk assessments are performed at appropriate stages of development and for decision making on issues arising.
Ensure deliverables are issued in accordance with the Design & Development plan.
Oversee inspection plans at CMO and UCB.
Provide expert support to internal UCB partners to assure systems are in place to manage novel new drug introducer technologies.
Facilitate investigations and resolution of issues relating to deviation and change management.
Review and approve deviations during Design & Development activities.
Lead/review critical investigations.
Track CAPA events and closure.
Oversee/track Design change controls.
Ensure application of ISO, MDR and GMP requirements where applicable.
Review and approve UCB documentation.
Review and approve submissions and responses.
Review and approve relevant sections of the device Technical Documentation File as required.
Release Clinical Trial Medical Devices.
Ensure Design History File (DHF) is in place.
Accommodate design & technology transfer and ensure systems alignment between vendor and UCB.
Performing focused assessments/audits.
Prepare Quality Agreement.
Minimum of 5 years working in the pharmaceutical/biologics/medical device industry in a quality management position. Operational GMP experience or clinical activities experience would be a distinct advantage.
Practical understanding of ISO13485: 2016, MDR, ISO14971 and 21CFR820 and part 4 requirements.
Practical experience in development or QA management of Software as Medical Devices, Vital signs Sensors or IVDs.
Practical experience in ISO13485, ISO14971, MDD/MDR and 21CFRpart 820 with main focus on Design Control.
Experience with 21CFR part 4 OR Medical Mobile Apps regulation.
Should have a US and EU knowledge of pharmaceutical and medical devices regulations together with quality principles and techniques.
Take accountability for decisions and actions taken.
Be proactive, confident and enthusiastic during the interaction with colleagues during team work and take the initiative to promote and share/implement best practices.
Must possess good interpersonal, verbal, and written communication skills and be able to confidently present information at interdepartmental and external meetings. Ensure free flow of information throughout the sphere of work.
Root cause analysis and risk management/assessment skills will be a distinct advantage.