Clinical Devices Development Quality Lead

Clinical Devices Development Quality Lead

UCB - Union Chimique Belge

Bulle, Switzerland

We are looking for a motivated Clinical Development Devices Quality Lead able to work in highly dynamic environment to join us in our Quality Assurance team.

About the role

This global position leads quality activities for medical devices assessment in the context of use in UCB sponsored clinical trials.

This will be achieved through:

• Providing Clinical Devices Quality input to cross functional teams dealing with complex and important projects and issues;
• Providing mentoring and guidance to other members of the Clinical devices extended team, supporting the Head of Devices and QMS Compliance and/or Development Devices Quality by deputizing for them at escalation meetings on request, and contributing to planning and resource prioritization decisions for Clinical Devices Quality activities;
• Contributing to planning and resource prioritization decisions for Clinical Devices Quality activities;
• Supporting UCB clinical teams in the qualification of devices and Vendors used in UCB sponsored Clinical Trials;
• Providing quality and compliance oversight as well as support to UCB activities in scope of ISO14155. This will be achieved through partnering with QA management at vendors and CRO sites and collaboration with UCB Technical Operations and other UCB teams.

What will you do

• Support UCB clinical teams in the qualification of Devices and Vendors used in UCB sponsored Clinical Trials (CT):
  • Perform activities as defined in process for Devices Assessments for Clinical Trial;
  • Answer quality questions related to the qualification of devices and vendors used in CT;
  • Work closely with GRA CMC Devices Leads, Medical Devices Safety and Vigilance Leads, DPWT, GCSO Innovation, Safety Alliance Managers, Strategic Partnering Lead and Clinical Development Quality lead to support efficiently the clinical teams;
  • Escalate risks, issues to the management;
  • Support process improvement;
  • Write Quality Agreement between UCB and the Vendor if applicable.
• Independently define prioritization, plan, coordinate and execute quality activities for Clinical Devices selection and assessment to ensure patient safety and to ensure that devices used in clinical trials and data generated are in compliance with applicable standards and regulations;
• Promote connection between Drug Delivery Devices development activities and Medical Devices used in clinical trials to build complete oversight of patient experience and allow for synergies between departments;
• Review clinical study documentation (e.g. IMP Handling Manual, protocol, …) from a quality perspective and provide feedback to the study team about complaints management in case of Devices deficiencies, Devices malfunction;
• Support inspections and investigations conducted by international and national authorities, including responsibility for the preparation of UCB sponsor sites for inspections;
• As required, review and coordinate the output of trends from audits, deviations and risk analyses prepared by colleagues, providing senior management and peers in other departments with a summary and analyses of signals across multiple clinical programs and improvement opportunities;
• Represent Medical Devices Quality at interdepartmental and project team meetings taking the leadership role when required and dealing with complex and difficult or important project issues;
• Deliver presentations to peers, senior management, and industry audiences, acting as a role model for change;
• Help develop, coach and mentor junior colleagues, generating enthusiasm and encouraging new ideas.

Interested? For this role we’re looking for the following education, experience and skills

• Master’s Degree;
• 5+ years of experience in a medical devices/pharmaceutical environment;
• Understanding the issues and challenges of selecting appropriate and fit for purpose devices from FIH to Phase 4 Drug clinical trials/studies;
• Thorough knowledge and understanding of Medical Devices Regulations (ISO14155, EU MDR, ISO 13485, 21CFR part 820);
• In-depth knowledge and understanding of applicable regulations, quality principles and relevant business processes relevant to use of Medical Devices in clinical trials. Experience as auditor and technical file management are optional but nice to have;
• Demonstrate leadership skills by ability to motivate, inspire others and resolve conflict;
• Demonstrate ability to independently analyse data and information to draw conclusions and make effective decisions;
• Must be able to effectively interact with internal and external stakeholders on many aspects of project and product related matters. Be confident in providing constructive feedback (and accepting feedback) from colleagues;
• Must be able to influence within cross functional teams to achieve a desired objective or outcome especially when working in a cross-cultural team environment;
• Fluent in English (written & spoken).

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