Devices Development Quality Lead

Devices Development Quality Lead

UCB - Union Chimique Belge

Braine L'alleud, Belgium

About the role

This global role leads to operational Quality Assurance for the development and commercialization of medical devices, combination products, and primary packaging, both internally and with key vendors. It also provides internal QA consultancy and ensures compliance with MDR, ISO standards, and GMP/cGMP requirements through close collaboration with vendor QA teams and UCB Technical Operations.

You will work with

This role collaborates closely with QA management at vendor sites, UCB Technical Operations, and various internal teams. It serves as a key liaison between external vendors involved in the design, development, and manufacturing of medical devices, combination products, and primary packaging, and internal stakeholders such as Corporate QA teams. The position also works in partnership with affiliate and operational teams to ensure effective QA service delivery and regulatory compliance across global activities.

What you will do

Design and development Quality assurance

• Oversee Design & Development activities, from Inputs definition through Design Transfer (including Validation/Verification activities);
• Review and approve relevant sections of the device design control documentation and/or Technical Documentation File as required;
• Review and approve protocols and reports for Verification & Validation studies, technology transfers, stability studies;
• Review and approve UCB documentation. Ensure Design History File (DHF) is in place;
• Ensure deliverables are issued in accordance with the D&D plan.

Vendor quality management

• Accommodate design & technology transfer and ensure systems alignment between vendor and UCB;
• Performing focused assessments/audits;
• Preparation and negotiation of Quality Agreements;
• Ensure systems alignment between vendor and UCB;
• Support risk register for the vendor, and follow up on mitigation activities;
• Oversee inspection plans at CMO and UCB.

Quality processes

• Facilitate investigations and resolution of issues relating to deviation and change management;
• Review and approve deviations;
• Track CAPA events and closure;
• Oversee/track change controls;
• Act as the Operational QA link between selected external vendors within the Medical Device and primary packaging portfolio;
• Assist with regulatory and customer inspections at Vendors. Specifically focus on: Inspection preparation, Support during inspection, Support post inspection observation closure.

General GMP

• Maintain Quality System elements associated with the ISO, MDR and GMP activities in a compliant manner;
• Drive/Support projects related to quality system improvement;
• Maintain key performance indicators (metrics) for key operational development QA activities and services associated with the Medical Devices, Combination Products and primary packaging activities;
• Maintain GMP compliance and inspection/audit readiness at all times. Support Medical Devices QA and Primary packaging departments in the inspection/audit preparation activities, during inspection/audit and for closure of inspection/audit observation with associated CAPA commitments.

Interested? For this position you’ll need the following education, experience and skills

• A master’s degree in a relevant scientific discipline is required;
• A minimum of 3 years’ experience in the Medical Devices sector, ideally in quality assurance;
• US and EU knowledge of pharmaceutical and medical devices regulations together with quality principles and techniques;
• Fluency in English (oral and written) is essential; French is a strong asset;
• Demonstrates accountability in decision-making and follow-through;
• Shows initiative, confidence, and enthusiasm in collaborative environments, actively promoting and implementing best practices;
• Strong team player, able to work effectively across functions and build constructive relationships;
• Capable of maintaining composure under pressure, with a resilient mindset in fast-paced or challenging situations;
• Excellent interpersonal and communication skills, with the ability to present confidently in cross-functional and external meetings, ensuring clear and open information flow;
• Experience in root cause analysis and risk management/assessment is highly desirable.