Commercial Device Quality Lead

il y a 6 jours

Brainel'Alleud, Belgique UCB S.A. Temps plein

**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 day-by-day 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

  • Medical Device Development Lead

    Il y a 7 mois

    Braine-l'Alleud, Belgique UCB Temps plein

    **Make your mark for patients** We are looking for a **Medical Device Development Lead** to join us in our Pipeline Devices organization based in Braine-l’Alleud, Belgium. **About the role**: You will focus on leading Medical Device development program(s). The main objectives of the Program Lead are to: - lead the design, development,...

  • Global Quality Lead Auditing Technology

    Il y a 4 mois

    Braine-l'Alleud, Belgique UCB Temps plein

    **Make your mark for patients** To strengthen our **Global Quality Auditing **department we are looking for a talented profile to fill the position of**:Global Quality Lead Auditing Technology** **- Braine l’Alleud, Belgium** **About the role** The Global Quality Lead for Auditing Technology develops and implements a risk-based Technology Quality...

  • Quality Lead

    Il y a 7 mois

    Braine-l'Alleud, Belgique BAXTER Temps plein

    **This is where you save and sustain lives** At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...

  • Vie Assistant Team Leader Medical Devices

    il y a 4 semaines

    Braine-l'Alleud, Belgique UCB Temps plein

    **Faites la différence pour les patients** UCB est une entreprise biopharmaceutique internationale ayant pour activités principales la recherche, le développement et la commercialisation de produits pharmaceutiques et biotechnologiques. Elle est spécialisée dans la recherche de solutions thérapeutiques pour des patients souffrant de maladies...

  • Vendor Quality Lead

    il y a 1 semaine

    Braine-l'Alleud, Belgique UCB Temps plein

    **Make your mark for patients** To strengthen our **External Supply Quality**department, we are looking for a talented profile to fill the position of**:Vendor Quality Lead** **- Braine l’Alleud, Belgium** **About the role** This role involves leading and providing expert QA guidance for strategic and operational Quality Assurance activities related to...

  • Cmc Development Quality Lead

    Il y a 3 mois

    Braine-l'Alleud, Belgique UCB Temps plein

    **Make your mark for patients** To strengthen our **Global Quality Assurance **department, we are looking for a talented profile to fill the position of**:CMC** **Development Quality Lead **- Braine l’Alleud, Belgium** **About the role** As part of the CMC Quality Management organization, specifically within the CMC Development Quality group, you will...

  • Devices & Packaging Technician

    Il y a 7 mois

    Braine-l'Alleud, Belgique UCB Temps plein

    **Make your mark for patients** **We are looking for a QC Devices & Packaging Technician** who is **detail-oriented, proactive, and reliable** to join our **Quality Control team** at our office in **Braine-l’Alleud, Belgique**. About the Role You will be responsible for controlling packaging items and conducting functionality tests on medical devices,...

  • Evidence Quality Lead

    il y a 2 semaines

    Braine-l'Alleud, Wallonia, Belgique UCB S.A. Temps plein

    Make your mark for patientsTo strengthen our Quality department, we are looking for a talented professional to fill the position of: Evidence Quality Lead– Braine l’Alleud, BelgiumAbout the roleAs part of the UCB Quality organization, the Early & Clinical Development Quality Lead (ECDQL) actively promotes quality and GLP GCP GVP compliance during the...

  • Clinical Drug Delivery Device Lead

    Il y a 4 mois

    Braine-l'Alleud, Belgique Amaris Consulting Temps plein

    **Who are we? **:**Amaris Consulting** is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade - this is made possible by an international team of 7,600 people spread across 5 continents and more than 60...

  • Clinical Drug Delivery Device Lead

    Il y a 4 mois

    Braine-l'Alleud, Belgique amaris Temps plein

    Job description We are seeking a methodical, detail-oriented Clinical Drug Delivery Device Lead with excellent interpersonal skills to join our Devices, Artwork, and Packaging team. This position can be based at one of our campuses in Braine l’Alleud, BE, Slough, UK, or Bulle, CH. About the Role This role focuses on providing support in the selection...

  • Vendor Quality Lead

    Il y a 3 mois

    Braine-l'Alleud, Belgique UCB Temps plein

    **Make your mark for patients** To strengthen our **Clinical Manufacturing Quality** department we are looking for a talented profile to fill the position of **Vendor Quality Lead** - **Braine l’Alleud, Belgium** **About the role** As Vendor Quality Lead, you will ensure that manufacturing operations for External Manufacturing Vendors and Partners meet...

  • Global Quality Lead Support

    Il y a 7 mois

    Braine-l'Alleud, Belgique Jefferson Wells Temps plein

    Location: **Braine L'Alleud** **#23107** **Global Quality Lead Support** Brabant Wallon - contracting Our partner is looking for a **Global Quality Lead Support** to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines. **What are your responsibilities?** This position...

  • Global Quality Lead Support

    Il y a 7 mois

    Braine-l'Alleud, Belgique Jefferson Wells Temps plein

    Location: **Braine-l'Alleud** **#24089** **Global Quality Lead Support**: Brabant Wallon - contracting Our partner is looking for a **Global Quality Lead Support** to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines. **What are your responsibilities?**: This position...

  • Team Leader Non Commercial Activities

    il y a 3 semaines

    Braine-l'Alleud, Belgique UCB Temps plein

    **Make your mark for patients** We are looking for a **Team Leader Non-Commercial Activities who** is a team player and autonomous to join our department based at our UCB campus located in **Braine-l’Alleud, Belgium.** **About the role.** In this role, you will organize production to ensure that customer needs are met while adhering to the company's...

  • Vendor Quality Lead Drug Product/qp

    Il y a 7 mois

    Braine-l'Alleud, Belgique UCB Temps plein

    **Make your mark for patients** To strengthen our **GMP/GSP Quality Operations **department we are looking for a talented professional to fill the position of**:Vendor Quality Lead Drug Product /QP** - Braine l’Alleud, Belgium** **About the role** This role supports the Qualified Person (QP) in batch release activities for Global products produced by...

  • Vendor Quality Lead

    Il y a 3 mois

    Braine-l'Alleud, Belgique UCB Temps plein

    **Make your mark for patients** To strengthen our **External & Supply Quality **department we are looking for a talented profile to fill the position of**:Vendor Quality Lead - External Supply Quality DS** **- Braine l’Alleud, Belgium** **About the role** This position will provide leadership and QA expertise in driving strategic and operational Quality...

  • Vendor Quality Lead

    Il y a 7 mois

    Braine-l'Alleud, Belgique UCB Temps plein

    **Make your mark for patients** To strengthen our **Quality Assurance - Early & Clinical Department Quality department,** we are looking for a skilled professional to fill the position of a Vendor **Quality Lead based in Braine l’Alleud-Belgium.** **About the role** This role will guide and provide comprehensive QA expertise to steer strategic and...

  • Engineering Quality Lead

    Il y a 5 mois

    Braine-l'Alleud, Belgique UCB Temps plein

    **Make your mark for patients** To strengthen our **External & Clinical Supply Quality** department we are looking for a **Engineering Quality Lead - Braine l’Alleud, Belgium** **About the role** The **Engineering Quality Lead** is a pivotal role within the External & Clinical Supply Quality Leadership team, ensuring quality oversight for the Global...

  • Vendor Quality Lead

    Il y a 7 mois

    Braine-l'Alleud, Belgique UCB Temps plein

    **Make your mark for patients** We're on the lookout for a Vendor Quality Lead who embodies leadership, expertise, and strategic thinking to join our team in the Global Quality Assurance department, based in our office in Braine, Belgium. **About the Role** This role is pivotal in providing leadership and deep QA expertise in driving strategic and...

  • Technicien(Ne) Controle Qualité Medical Devices

    Il y a 7 mois

    Braine-l'Alleud, Belgique UCB S.A. Temps plein

    **Faites la différence pour les patients** Afin de renforcer notre **département Contrôle Qualité**, basé au sein de notre centre à Braine l’Alleud, Belgique, nous recherchons un(e) **Technicien(ne) Quality Control Medical Devices**. Notre futur collègue intégrera l'équipe dédiée à l’Incoming Packaging en qualité d'analyste d’articles de...