- Develop and maintain a strategic quality roadmap/plan to execute on specific strategic initiatives that will deliver the long-term development strategy, and to document e.g. critical to quality parameters and measures (to be) taken applicable to all development phases for the assigned compound(s), in consideration of systems applied and vendors involved.
- Seek opportunities at a compound level aimed at establishing research/study design and vendor oversight that is fit for purpose, with focus on pro-actively ensuring the quality of downstream regulatory documentation, but also at the level of the systems and solutions applied to support developmental activities.
- Contribute to the risk mitigation program established for UCB clinical programs, prospectively identifying critical quality risk factors, their potential impact, and developing efficient processes or solutions to manage the risks.
- Independently plan, coordinate and execute quality activities (e.g. data review, spot checks) in accordance with the risk mitigation plans to validate the systems and processes established to ensure subject safety and protection and to ensure that clinical trials are performed and data are generated in adherence with the study protocol, targeted endpoints and in compliance with regulations.
- Review and coordinate the output of trends from audits and risk analyses prepared by colleagues, providing senior management and peers in other departments with a summary and analyses of the comparative risks and outcomes across multiple clinical programs.
- Leverage internal stakeholders and SME network to develop appropriate action plans, decisions and ensure efficient actions are taken to ensure compliance.
- Conduct moderate to complex analytics and qualitative assessments to deliver insights, independently from the business or other quality functions.
- Master's degree in relevant scientific or healthcare related field.
- 10+ years of experience working in the (bio)pharmaceutical industry with a minimum of 5+ years in the early and/or clinical development operational and/or quality domain.
- Proficient in GCP regulations, applicable technical aspects, and regional specificities.
- Ability to translate regulatory and quality expectations into operations based on experience and knowledge of quality principles.
- Expertise in Neurology, Immunology and Advanced Therapeutic Medicinal Products preferred.
- Proven track record in GCP quality auditing, inspection management and clinical quality management.
- Demonstrated ability to manage quality and compliance issues respectfully, with diligence, rigor, within timeliness, and in all transparency.
- Experience presenting complex projects and issues in a clear succinct manner.
- Must demonstrate excellent planning, organizational, presentation and training skills.
- Experience in other GxP areas (GLP, GVP, GMP, GDP) is an asset.
-
Vendor Quality Lead
1 week geleden
UCB Braine-l'Alleud, België**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 piv ...
-
Quality System Management Lead
2 dagen geleden
UCB Braine-l'Alleud, België**Make your mark for patients** · We are looking for a **GxP and GMP/GDP** **Quality Management System Lead **who is passionate, knowledgeable, and proactive to join us in our **GxP Quality Management Systems and Learning** team, based in our office in **Braine l'Alleud**, Belgiu ...
-
Global Quality Lead Support
1 week geleden
Jefferson Wells Braine-l'Alleud, BelgiëLocation: · **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 marketi ...
-
Logistics Quality Lead
2 dagen geleden
Madison IT & Engineering Recruitment Brussels, België**Beschrijving**: · **MEDICAL** - Onze klant is een **wereldspeler** die toegewijd is aan het creëren, innoveren en leveren van hoogwaardige medische apparatuur die globaal dagelijks het verschil maken in mensen hun leven. De producten zijn ontworpen, geproduceerd en worden behan ...
-
Data Quality and Governance Lead
5 dagen geleden
Smals Brussels, BelgiëChez Smals, plus de 2000 professionnels façonnent, chaque jour, l'avenir en s'investissant dans « l'ICT for Society ». Ces systèmes ICT de pointe permettent à nos clients de garantir des services encore plus performants dans des domaines tels que le travail, la famille et la sant ...
-
Quality Lead Specialist
1 week geleden
Johnson Controls International Groot-Bijgaarden, België**WAT GA JE DOEN?** · - Het beheer van het kwaliteitsmanagementsysteem (KMS) voor België; · - Onderhoud van het KMS op de SharePoint website; · - Harmonisatie van operationele processen en het delen van best practices · - Ondersteuning geven aan de onderneming als geheel en teven ...
-
Global Quality Lead Gvp Audit Compliance
1 week geleden
UCB S.A. Braine-l'Alleud, België**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 backgro ...
-
Product Quality Lead
6 dagen geleden
Thermo Fisher Scientific Seneffe, België**Mission of function** · Production of bipharmaceuticals products conform to the requirements of international quality defined by FDA, EMEA, ICH, etc. · Quality Project Lead is the single point of contact for all requests linked to operational quality assurance related to produc ...
-
Hardware Quality Lead
3 dagen geleden
Uptime ICT Bruxelles, België VoltijdPour un de nos clients basé à Bruxelles, nous sommes à la recherche d'un Team Leader IT Support (h/f) à temps plein. Vous gérer l'équipe support, helpdesk et téléphonie afin d'assurer la mise à disposition d'outils de bureautique et liés aux postes de travail (PC's, Laptops, impr ...
-
Asset Quality Lead
3 uur geleden
UCB Braine-l'Alleud, BelgiëMake your mark for patients · We 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 role · As part of the Global Qu ...
-
quality lead, partner
3 dagen geleden
Jefferson Wells Walloon Brabant, BelgiëBrabant Wallon – contracting Our partner is looking for a Global Quality Lead Solutions Partner to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines. Product Change Control Committee preparati ...
-
Clinical Quality Lead
6 dagen geleden
UCB Braine L'alleud, België OTHERMake your mark for patients · We 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 role · As part of the Global Quali ...
-
Lead Quality Project Manager
1 week geleden
Linesight Farciennes, BelgiëOverview: · As a **Quality Lead** **Project Manager (Data Centre)** at Linesight, you will work with highly experienced, culturally diverse, and passionate teams nurturing a strong social dynamic and a shared sense of achievement. You will gain vast industry experience that will ...
-
Primary Packaging Quality Lead
4 dagen geleden
UCB Braine-l'Alleud, BelgiëMake your mark for patients · We are looking for a Primary Packaging Quality Lead to join us in our Devices and Wearable Tech. Quality team, based in our office in Bulle, Switzerland. · About the role · This global position drives operational Quality Assurance activities fo ...
-
Data Quality and Governance Lead
6 dagen geleden
Smals Saint-Gilles, België VoltijdChez Smals, plus de 2000 professionnels façonnent, chaque jour, l'avenir en s'investissant dans « l'ICT for Society ». Ces systèmes ICT de pointe permettent à nos clients de garantir des services encore plus performants dans des domaines tels que le travail, la famille et la sant ...
-
Data Quality and Governance Lead
1 week geleden
Smals Brussels, BelgiëEn tant que Data Quality & Governance Lead, vous êtes rattaché au « Data Office » qui est responsable de la gouvernance des données, du contrôle qualité des données ainsi que du développement des solutions de Business Intelligence de l'INAMI. Vous rapportez au Data Governance Man ...
-
Data Quality and Governance Lead
6 dagen geleden
Smals Brussels, België VoltijdVotre role · En tant que Data Quality & Governance Lead, vous êtes rattaché au « Data Office » qui est responsable de la gouvernance des données, du contrôle qualité des données ainsi que du développement des solutions de Business Intelligence de l'INAMI. Vous rapportez au Data G ...
-
Business Process Quality Lead/associate Director:
6 dagen geleden
GSK Wavre, België**Site Name**: UK - London - Brentford, Belgium-Wavre, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence · **Posted Date**: Feb · **Business Process Quality Lead/Associate Director** · We're combining the power of genetic and genomic insights into what causes ...
-
Data Quality and Governance Lead
1 week geleden
Smals Brussels, BelgiëEn tant que Data Quality & Governance Lead, vous êtes rattaché au « Data Office » qui est responsable de la gouvernance des données, du contrôle qualité des données ainsi que du développement des solutions de Business Intelligence de l'INAMI. Vous rapportez au Data Governance Man ...
-
Global Quality Lead Solutions Partner
8 uur geleden
Jefferson Wells Braine-l'Alleud, België VoltijdBrabant Wallon – contracting · Our partner is looking for a Global Quality Lead Solutions Partner to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines. Job descriptionProduct Change Control C ...
Clinical Quality Lead - Braine-l'Alleud, België - UCB
Beschrijving
Make your mark for patients
We 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 role
As part of the Global Quality Assurance Organization, the Clinical Quality Lead (CQL) is responsible to create value, by providing quality directions and insights that protect patients, sustain compliance, including driving inspection readiness activities aiming for real-time readiness, and preserve UCB's reputation.
The CQL will focus on driving quality and compliance in the early and clinical development phases of UCB compounds, from candidate selection to life cycle management, at a global level and in partnership with the Early Solutions and Development Solutions organizations and external stakeholders.
The CQL serves as a key partner for the overall early and clinical development strategy at a compound level, in support of Sr R&D Leadership to develop and shape the future portfolio strategy as well as to align for execution and implementation.
Who you'll work with
The responsibilities and activities of the ECDQ team span all development phases of the UCB product portfolio until the granting of marketing authorization and at a global level. The key responsibilities of our ECDQ Team are to ensure that quality systems are in place and monitored to prevent and pro-actively mitigate risks that could potentially impact the safety of patients and the quality of the data in our clinical trials.
The CQL will also ensure quality strategies are developed at a Compound Level, strategic and specialty vendors are selected and operating in adherence with UCB expectations and Global Health Authority inspections are appropriately led, managed.
What you'll do
Interested? For this role we're looking for the following education, experience, and skills:
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
