Device Development Quality Lead

UCB

  • Braine-l'Alleud, Brabant Wallon
  • CDI
  • Temps-plein
  • Il y a 19 jours
Make your mark for patientsTo strengthen our Devices and Wearable Tech Quality department we are looking for a talented profile to fill the position of: Device Development Quality Lead – Braine l’Alleud, BelgiumAbout the roleThis 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 withThis 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 doDesign 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 bachelor’s or 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
  • 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
Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.Why work with us?
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on EMEA-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

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