In Vitro Diagnostic Devices Quality Lead

Contenuto del lavoro

To strengthen our Diagnostic Devices Quality team, we are looking to fill the position of: In-Vitro Diagnostic (IVD) Devices Quality Lead.

The person would preferably be based in Braine-l’Alleud in Belgium (or in Bulle in Switzerland).

This global position leads operational Quality Assurance activities to ensure compliance oversight into the selection, development and commercial use of In-Vitro Diagnostics devices to support UCB drugs portfolio.

The role works closely with internal and external business partners in driving quality into the IVD pre- and post-market activities, covering rare diseases, including gene therapy. It provides QA input to cross functional teams dealing with complex and/or important projects and issues through clinical and CMC phases.

It will as well 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 position reports to the Head of Diagnostic Devices Quality.

Your main accountabilities will be:

• Lead or support implementation of quality process improvement and maintain applicable QMS sections to ensure consistency and compliance to EU IVDR, US FDA and other territories.
• Train and influence UCB internal stakeholders to IVD requirements/processes in connection to Pharma and GCP processes.
• Participate to IVD’s requirements definition, partners selection and monitoring.
• Oversee Design & Development activities to IVD partners.
• Interact as IVD’s 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, experience and skills:

• Master’s degree in a relevant discipline (Pharmaceutical, Biomedical-Engineering, Biotechnology, Biology, or related fields).
• At least 2 to 5 years of experience in Quality OR Clinicals studies of IVD’s or Medical Devices.
• Good knowledge of regulations, standards and guidance applicable to IVD products including (but not limited):
• EU IVDR 2017/746
• PIC/S standards
• ISO 15189
• ISO 20916
• ISO 14155
• ISO 13485
• ISO 14971
• ISO-IEC 62366
• ISO-IEC 62304
• 42 CFR part 482
• 21 CFR part 820 & 812
• CLSI Guidelines
• Experience with IVD regulations of RUO products, Lab Developed Tests, Clinical Trial Assay, Commercial IVD MD and processes for design control, risk management, conformity assessments, vigilance and post-market surveillance.
• Basic statistical knowledge and audit experience would be advantageous.
• Very good command in English (both written & spoken).

Soft skills:

• Excellent presentation and interpersonal skills: being able to communicate clearly (both orally and in writing) to UCB sites, partners and vendors.
• Organization and planning skills: being able to prioritize according to Compliance and Patient Safety Risk.
• Negotiation skills: being able to build partnerships internally and externally.
• Analytical mindset: being able to understand complex compliance requirements.

Why you should apply?

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.