Commercial Device Quality Lead - Braine-l'Alleud, België - UCB S.A.

UCB S.A.
UCB S.A.
Geverifieerd bedrijf
Braine-l'Alleud, België

2 weken geleden

Sophie Dubois

Geplaatst door:

Sophie Dubois

beBee Recruiter
Beschrijving

Make your mark for patients


To strengthen our
Quality Assurance
team, we are looking for a high caliber, self-motivated
, Commercial Device Quality Lead based in
Braine l'Alleud, Belgium.



At UCB everything we do starts with a simple question: "How will this make a difference to the lives of people living with severe diseases?" We do that by connecting our ground-breaking science with patients and their families around the world living with the physical and social burdens of autoimmune and neurological disorders. Those connections offer new perspectives, drive innovation, and offer the hope of a new generation of therapies that will help improve lives on a global scale.

You like to work in an
environment where you can**:

  • Manage quality assurance matters with one or more supplier(s) of medical devices, devices constituent parts of combination products or containers closure systems ("primary packaging") and support the lifecycle of the same product (s).
  • Be part of a "vendor team" involved in daybyday activities with suppliers and collaborations with local UCB quality functions like quality incoming controls and final assembling of the components delivered by the suppliers.
  • Collect customer complaints and deviations results, proposing change control initiatives and continuous risk management reviews required by the post market surveillance activities. In this activity you will work in collaboration with medical devices TST team and Regulatory teams and, occasionally, with Regional UCB quality representative, in support to answer to authorities, distributors, customers.
  • You will ensure compliance to Medical Devices/Combinations products regulations, ISO requirements and GMP/cGMP compliance from a quality, safety and efficacy point of view.
  • You can be involved in the maintenance and improvements of UCB quality management system.
  • You have a previous experience in medical devices, combination products or containers closure systems represents an asset, but the position holder could also have experience in pharmaceutical companies.
  • You have good communications skills, capacity to lead initiatives at suppliers' side.

Interested? For this position you'll need the following
education, experience
and skills**:

  • You have general professional proficiency in English
  • You know about basic SW tools, MS Office package (word/PS/Excel)
  • You are able to take accountability for decisions and actions taken.
  • You have good interpersonal, verbal, and written communication skills and are able to confidently present information at interdepartmental and external meetings.
  • You have some redactional ability
  • You have experiences in supplier management and QMS
  • You have a practical understanding of ISO 13485:2016, EU MDR, ISO 14971 and 21CFR820 and part 4 requirements OR equivalent pharma standards
  • You know about product/processes risk management principles and tools (DFMEA, PFMEA)
  • You have a basic knowledge in Manufacturing Process Validation principles and inspections sampling procedures

Plus:

one or more of the following competences:

  • FDA/EU guidelines on medical devices / combination products / container closure systems
  • Experience in statical analysis applied to process validations
  • Previous experience in electronic QMS

Why you should apply
We can offer you an informal and open working environment that does not lock scientists into structure and hierarchy. Freedom to take space to pursue your own ideas and make a difference. Opportunity to gain internal and external visibility through interactions with other UCB teams and with world-renown academic investigators.

Opportunity to grow both as a drug hunter and leader through participation in project teams and our career/personal development programs.


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.

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 for 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 equitable opportunities to do their best work.

We 'go beyond' to crea
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