IVD Diagnostic Devices Global Quality Lead

Job content

Make your mark for patients.

We’re here because we want to build the future and transform patients’ lives for the better.

At UCB, our people are our experiences and achievements, our passion and drive. That’s why we’re looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients. We promote an environment of diversity, openness, and respect where people can make valuable contributions.

An exciting journey lies ahead. Will you join us in pushing the boundaries of what’s possible?

To strengthen our Global Quality Assurance team, based in our hub in Braine l’Alleud, Belgium, we are looking to fill the position of: IVD Diagnostic Devices Global Quality Lead.

As an IVD Diagnostic Devices Global Quality Lead, you like to work in an environment where you can:

• Drive operational Quality Assurance activities for development and commercial use of In-Vitro Diagnostics devices.
• Work closely with internal and external business partners in driving quality into the IVD pre- and post-market activities required to support UCB drugs portfolio covering rare diseases, including gene therapy.
• Provide QA input to cross functional teams dealing with complex and/or important projects and issues through clinical and CMC phases.
• Provide specific internal QA support/consultancy for development and commercial activities related to diagnostics and medical devices internally and at key vendors especially for use in clinical studies.
  

This Will Be Achieved Through

• Close partnering with QA management at vendors sites and collaboration with UCB Technical Operations and other UCB teams.
• Acting as QA specialist for IVDs to provide quality and compliance oversight to support development and commercial activities
• Implementing and maintaining appropriate quality processes to ensure compliance with the latest and evolving regulatory standards and internal policies.
• Ensuring compliance to Medical Devices and In-Vitro Diagnostics regulations, applicable ISO requirements and GMP/GCP compliance from a quality, safety and efficacy point of view.
  

You will report to the Head of Medical Devices QA and be involved in people management responsibilities.

As an IVD Diagnostic Devices Global Quality Lead, you will contribute by:

Quality Processes

• Act as process owner for IVDs and companion diagnostics development related activities by introduction of relevant requirements in the Medical Devices QMS.
• Lead or support implementation of quality process improvement to meet evolving requirements with specific focus in use of medical devices in medicinal clinical studies including mechanical and digital medical devices.
• Define priorities, build processes and maintain applicable QMS sections (g. Design control, GSPR, Risk management SOPs, templates…) to ensure consistency and compliance to IVDR, FDA and other regions (China, Japan,…). Influence organization to meet defined requirements including linkage to pharma and GCP processes.
• Train UCB internal stakeholders to IVD requirements/processes and provide expert advice, support and management for technical operational QA and general QA matters for specific vendors, on behalf of UCB, in design/development and/or testing/manufacturing of IVD devices ensuring implementation of applicable regulatory requirements.
  

Design And Development Quality Assurance

• Participate to IVDs requirements definition and partner selection through Request for quotation assessment, due diligence and audit support
• Oversee Design & Development activities at IVD partners: Product development cycle, Risk management, Target Product Profile, Co-development Companion Diagnostic Product and Therapeutic Product
• Ensure application of ISO 15189:2012, ISO 20916:2019 and CLSI guidelines
  

Stakeholders Management

• External parties, Vendor quality management:
• Manage QA aspects of Request for Information/ Quotation, due diligence, audits
• Provide inputs and review contracts such as QAA, MSA’s, SOW’s etc
• Participate to definition and deployment of project organization and collaboration models
• Internal parties:
• Assess vendor submission risks.
• Interact as IVDs QA point of contact with Regulatory CMC & Devices, Pharmaceutical teams, Research Quality, Clinical, Biomarker team in early phase development and Commercial organization
  

Interested? For this position you’ll need the following education,experienceand skills:

• Master’s degree related to the field of activity (Pharmaceutical, Biomedical-Engineering, Biotechnology, Biology, or related science)
• 2 to 5 years of experience minimum in a Quality role and overall 10+ years, dealing with IVD design and development activities, verification and validation activities, usability engineering, commercialization, risk management, performance validation (including analytical and clinical performance and, scientific validity) and all other aspects to achieve an IVDR compliant product e.g. for bioassays, bio markers, (also used to support clinical development).
• Solid knowledge of regulatory requirements, standards and guidance associated to IVD products including but not limited to IVDR ((EU) 2017/746), PIC/S, standards, ISO15189, ISO20916, ISO14155, ISO13485, ISO14971, IEC62366 42CFR part 482, 21CFR part 820, CFR part 812, CLSI Guidelines, project management, auditing and FDA Guidance medical devices and IVD`s used in Clinical Studies.
• Knowledge in and experience with application of regulatory requirements associated IVD devices such as but not limited to assays validated for clinical trial starts, use of RUO products, Lab developed tests, IVD`s used in gene therapy programs, conformity assessments by notified bodies, design verification and validation.
• Good understanding of design control and risk management requirements through experience in design and development activities including commercialization for IVD
• Analytical mind-set to understand complex Compliance and Regulatory issues associated with IVD products both in a commercial set up as used during clinical trials.
• Excellent presentation, training skills, interpersonal, negotiation, planning, and organizational skills.
• Able to prioritize according to Compliance and Patient Safety risk.
• Ability to build partnerships internally and externally.
• Ability to communicate clearly (both orally and in writing) to UCB sites, partners and vendors.
• Statistical knowledge (or knowledge of statistical principles) would be helpful.
• Previous audit experience could be advantageous.
• Communicating fluently in English both speaking & in writing (additional languages advantageous).
  

About Us.

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 7,600 people in all four corners of the globe, inspired by patients and driven by science.

At UCB, everything we do start with a simple question: “How will this create value for people living with severe disease?”. We are on a journey to become the patient-preferred biopharma leader by delivering medicines and solutions that improve lives. We want to ensure the creation of patient value, now and into the future, while contributing to a society where a population of 8 billion people and more should be able to live a good life within limited resources of one planet.

Curious to know more? Please visit our website www.ucb.com .

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.