Vendor Quality Lead Drug Product/QP

il y a 3 jours

Brainel'Alleud, Wallonie, 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 third parties, including QA review of batch documents, issuing batch certificates, and transactional release. It involves pharmaceutical drug product release at UCB Pharma SA Belgium and deputizing for the QP during absences.

You will work with

The role also provides leadership and QA expertise in managing Quality Assurance activities with Global Vendors (CMOs) involved in GMP manufacturing for UCB products. This is done through collaboration with QA management at UCB, Product Global Quality Leads, Vendor Quality Leads, and UCB Technical Operations and other teams.

What you will do

Vendor Quality Lead (VQL):

  • Act as the main QA contact for investigations, deviations, out-of-specifications and audit observations with assigned vendors. Conduct QA reviews and collect supportive information for assessment
  • Manage and track key performance indicators for QA activities and services using defined tools
  • Ensure all quality agreements with vendors are in place, maintained and periodically reviewed
  • Ensure timely completion, review and documentation of Product Quality Review by vendors in the UCB Controlled Documents System.
  • Participate in regular vendor meetings as the QA representative, present issues and drive quality performance
  • Manage the follow-up and investigation of quality complaints with vendors and coordinate responses
  • Collaborate with the Vendor team and Global Quality Lead for root cause analysis and coordinate vendor quality-related investigations
  • Oversee UCB audits and Health Authority inspections related to vendors, track audit observations, and manage CAPA plans
  • Ensure review of relevant RA dossier section related to the assigned vendors
  • Cover the entire product life cycle from initial commercialisation including Technology Transfer/Knowledge transfer, commercial, product improvements to phase out for the assigned vendors

Qualified Person (QP):

  • Perform the QA review of batch documents, assist the QP and issue batch certificates for product release and distribution.
  • Perform product release transactions in SAP and maintain the batch release register
  • Collaborate with Vendor Teams and CMOs to resolve document errors supporting release
  • Liaise with other departments and Affiliates to support the drug product release process and supply post-release documents
  • Assist Global Regulatory Affairs and Global Quality Leads with submission document requests
  • Review and approve Drug Substance and Drug Product specifications for global commercial products
  • Work closely with Technical Operations to ensure timely product disposition and effective QA services for commercial activities, including launches in new countries

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

  • It is mandatory to be Industrial Pharmacist and registered as Qualify Person from Belgian Health Authorities (registration number)
  • At least 5 years' experience in GMP environment, manufacturing process for injectables (aseptic, post sterilizable, pre-filled syringes, lyo in vials) and quality systems (deviation, CC, OOS, complaints, ...)
  • Experience in CMO management will be an additional strength as well as experience with regulatory submissions or auditing process
  • Must have excellent proficiency in English, both written and spoken. Ability to act independently and manage complex situations affecting multiple departments
  • Effectively interact with and influence senior internal and external stakeholders on project and product matters
  • Excellent interpersonal, verbal, and written communication skills, especially with senior management
  • Generate team commitment, encourage new ideas, and act as a role model
  • Skilled in operating in a multi-cultural environment
  • Analyze data independently, identify risks, propose corrective actions and develop innovative solutions through extensive quality experience

If you are interested to learn more about R&D within UCB, please find more information here R&D at UCB.

RANDATUCB

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 with 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 create value for our patients, and always with a human focus, whether that's on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

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.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on on EMEA- Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

  • Vendor Quality Lead

    il y a 2 semaines

    Braine-l'Alleud, Wallonie, Belgique UCB Temps plein

    Make your mark for patientsWe'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 RoleThis role is pivotal in providing leadership and deep QA expertise in driving strategic and operational Quality...

  • Vendor Quality Lead

    il y a 18 heures

    Braine-l'Alleud, Wallonie, Belgique UCB Temps plein

    Make your mark for patientsTo 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 operational Quality...

  • Vendor Quality Lead

    il y a 2 semaines

    Braine-l'Alleud, Wallonie, Belgique UCB Temps plein

    Make your mark for patientsTo 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 roleThis role will guide and provide comprehensive QA expertise to steer strategic and operational Quality Assurance...

  • Vendor Quality Support

    il y a 4 semaines

    Braine-l'Alleud, Wallonie, Belgique Randstad Temps plein

    We are looking for a Vendor Quality Support, for one of our clients based in Braine-l'Alleud/Wavre.Don't hesitate to contact me : anne- - Life Sciences Wallonie.This is a contract as a Consultant (employee or freelance). responsabilitésAs a Vendor Quality Specialist, here are the tasks: Review annual stability protocol and reports. Communicate any trends to...

  • Vendor Quality Support

    il y a 1 mois

    Braine-l'Alleud, Wallonie, Belgique Randstad Temps plein

    We are looking for a Vendor Quality Support, for one of our clients based in Braine-l'Alleud/Wavre.Don't hesitate to contact me : anne- - Life Sciences Wallonie.This is a contract as a Consultant (employee or freelance). responsabilitésAs a Vendor Quality Specialist, here are the tasks: Review annual stability protocol and reports. Communicate any trends to...

  • Vendor Quality Lead Bio Ds, Gmp Gsp Quality

    il y a 2 semaines

    Braine-l'Alleud, Wallonie, Belgique UCB Temps plein

    Make your mark for patientsTo strengthen our Quality Assurance team, based in Braine, Belgium, we are looking for a talented individual to fill the position of:Vendor Quality Lead Bio DS, GMP GSP Quality Operations.About the role:This position will provide leadership and QA expertise in driving strategic and operational Quality Assurance activities...

  • Drug Product Project Lead

    il y a 2 semaines

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

    Make your mark for patientsWe are looking for a Drug Product Project Lead who is to join us in our Product Development team, based in Braine-l'Alleud, BelgiumAbout the roleThe Drug Product (DP) Project Lead is responsible for:one or more development project depending on project complexity and phase of development (from preclinical to commercial launch and...

  • Quality Partner Biotech Sciences Ops&qp

    il y a 2 semaines

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

    Make your mark for patientsTo strengthen our Quality Assurance team, we are looking for a high caliber, self-motivated, Quality Partner Biotech Science Ops & QP 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...

  • Drug Product Expert

    il y a 2 semaines

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

    Make your mark for patientsWe are looking for a Drug Product Expert to join us in our Product Development team, based in Braine-l'Alleud, BelgiumAbout the role Lead and run assigned project work packages/transversal activities. Contribute to project Drug Product (DP)subteam as SME representing own area of expertise and actively contributing to the...

  • Senior SME Drug Product Expert

    il y a 5 jours

    Braine-l'Alleud, Wallonie, Belgique UCB Temps plein

    Make your mark for patientsWe are looking for a Senior SME Drug Product Expert who is innovative, collaborative, and proactive to join our Pharmaceutical Development team, based at our UCB campus in Braine-l'Alleud, Belgium. About the RoleAs a Senior SME Drug Product Expert, you will lead and manage project work packages related to drug product development...

  • QA Qp Packaging

    il y a 2 semaines

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

    **Make your mark for patients**QA QP Packaging OfficerNous recherchons un QA QP Packaging Officer pour nous rejoindre dans notre équipe QA Opérations, basé dans le campus UCB situé à Braine-l'Alleud, Belgique.**À propos du rôle**En collaboration avec le management, le QA QP Packaging Officer est responsable de la mise en place et de la maintenance...

  • Clinical Quality Lead

    il y a 2 semaines

    Braine-l'Alleud, Wallonie, Belgique UCB Temps plein

    Make your mark for patientsWe are looking for a Clinical Quality Lead who is cooperative, insightful and quality-minded to join us in our Quality Assurance team, based in either our **Raleigh NC or Brain Belgium** office locations.About the roleAs part of the Global Quality Assurance Organization, the Clinical Quality Lead (CQL) is responsible to create...

  • Gene Therapy Drug Product Scientist

    il y a 2 semaines

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

    Make your mark for patientsWe are looking for a Gene Therapy Drug Product Scientist who is a hands-on team player with a keen interest for innovation and a can-do attitude to join us in our Gene Therapy Process & Analytical Sciences team, based in Belgium (Braine-l'Alleud and Leuven sites).About the roleYou will be responsible for supporting Drug Product...

  • Clinical Quality Lead

    il y a 4 semaines

    Braine-l'Alleud, Wallonie, Belgique UCB Temps plein

    Make your mark for patientsWe are looking for a Clinical Quality Lead who is cooperative, insightful and quality-minded to join us in our Quality Assurance team, based in either our Raleigh- NC or Brain - Belgium office locations. About the roleAs part of the Global Quality Assurance Organization, the Clinical Quality Lead (CQL) is responsible to create...

  • Asset Quality Lead

    il y a 4 semaines

    Braine-l'Alleud, Wallonie, Belgique UCB Temps plein

    Make your mark for patientsWe are looking for a Asset Quality Lead who is cooperative, insightful and quality-minded to join us in our Quality Assurance team, based in either our Raleigh- NC or Brain - Belgium office locations. About the roleAs part of the Global Quality Assurance Organization, the Asset Quality Lead (AQL) is responsible to create value, by...

  • Clinical Quality Lead

    Il y a 2 mois

    Braine-l'Alleud, Wallonie, Belgique UCB Temps plein

    Make your mark for patientsWe are looking for a Clinical Quality Lead who is cooperative, insightful and quality-minded to join us in our Quality Assurance team, based in either our Raleigh- NC or Brain - Belgium office locations. About the roleAs part of the Global Quality Assurance Organization, the Clinical Quality Lead (CQL) is responsible to create...

  • Asset Quality Lead

    il y a 1 mois

    Braine-l'Alleud, Wallonie, Belgique UCB Temps plein

    Make your mark for patientsWe are looking for a Asset Quality Lead who is cooperative, insightful and quality-minded to join us in our Quality Assurance team, based in either our Raleigh- NC or Brain - Belgium office locations. About the roleAs part of the Global Quality Assurance Organization, the Asset Quality Lead (AQL) is responsible to create value, by...

  • Global Quality Lead Gvp Audit Compliance

    il y a 2 semaines

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

    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...

  • QA Officer Drug Substance

    il y a 2 semaines

    Braine-l'Alleud, Wallonie, Belgique UCB Temps plein

    Make your mark for patientsTo strengthen our QA Operations department, we are looking for a skilled professional to fill the position of:QA Officer Drug Substance - Braine l'Alleud, BelgiumAbout the roleThis role entails collaborating with management to oversee the implementation and maintenance of a robust Quality Management System at the UCB Braine Site....

  • QA Officer Drug Substance

    il y a 5 jours

    Braine-l'Alleud, Wallonie, Belgique UCB Temps plein

    Make your mark for patientsTo strengthen our QA Operations department, we are looking for a skilled professional to fill the position of: QA Officer Drug Substance – Braine l'Alleud, Belgium About the role This role entails collaborating with management to oversee the implementation and maintenance of a robust Quality Management System at the UCB Braine...