Global Quality Lead Gcp Auditing
il y a 1 semaine
Make your mark for patients
To strengthen our
Quality Auditing & Compliance department we are looking for a talented person to fill the position of
:Global Quality Lead GCP Auditing & Compliance - Braine l'Alleud, Belgium**
About the role
The Global Quality Lead for GCP Auditing & Compliance will develop and execute a GCP audit strategy, delivering a risk-based audit program to ensure the quality and compliance of UCB's GCP Quality Systems.
This role ensures that UCB's clinical trials adhere to regulatory requirements, contractual agreements and UCB's Global Quality Management System, effectively identifying and mitigating compliance risks.
You will work with
The Quality Organization, such as Early & Dev Solutions Quality Management, Quality Systems & Intelligence and other auditing teams within Quality Auditing & Compliance.
Moreover, you will collaborate with stakeholders outside the Quality Organization, including Global Clinical Sciences & Operations, Global Clinical Development and Statistical Science & Innovation.
Additionally, engagement with International Regulatory Authorities occurs through inspections.What you will do
Internal & External Auditing
- Develop and lead a risk based GCP audit program, assessing UCB's quality system compliance
- Conduct GCP audits per the annual program, including investigator sites, vendors and systems
- Audit potential new vendors/partners for qualification before contracts
- Prepare, support and follow up on external GCP audits, ensuring they align with UCB processes and standards
- Manage audit findings, responses, and CAPAs in the Audit Management Tool, escalating issues as needed
- Ensure timely and accurate audit data entry in the Audit Management Tool
- Collaborate on issuing KPIs and dashboards for trend analysis and risk assessment across the GCP quality system
- Provide data and feedback to internal stakeholders on quality/performance indicators and compliance status
- Escalate GCP compliance concerns and provide expert guidance on CAPAs and quality improvements
- Report critical compliance risks/issues to Quality Auditing & Compliance Leadership.
Consulting, Educating, Quality Improvement, and External Focus:
- Leverage Regulatory Surveillance, Indrustry benchmarking, business, regulatory, and quality knowledge to influence quality approaches and ensure compliance with regulatory guidelines and UCB standards
- Participate in medium
Interested? For this position you'll need the following education, experience and skills
- Bachelor's or Master's degree
- Substantial and broadranging experience in the pharmaceutical/biotechnology sector, including significant time in GCPrelated areas
- Required experience in Clinical Data Management and/or Biostatistics
- At least 5 years of experience in auditing, and 5 years in clinical roles or a combination of both
- Proven experience in leading a full range of GCP audits for internal processes/units and external partners or vendors
- Indepth knowledge of ICH-GCP, applicable domestic and international regulations, quality principles and relevant business processes
- High personal integrity with a commitment to patient welfare and ethical behavior
- Fluent in English; additional languages are a plus
- Willing to travel nationally and internationally, up to 30% of the time
- Selfstarter, reliable, positive, and able to manage workload and priorities effectively
- Confident presenter and communicator, capable of representing the company and delivering clear messages to various audiences
- Skilled negotiator, able to influence and gain cooperation from stakeholders, including senior management, during audits
- Excellent planning and organizational skills with a structured approach
- Builds strong internal and external partnerships
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 y-
Global Quality Lead GCP Auditing
il y a 1 semaine
Braine-l'Alleud, Wallonie, Belgique UCB Temps pleinMake your mark for patients To strengthen our Quality Auditing & Compliance department we are looking for a talented person to fill the position of: Global Quality Lead GCP Auditing & Compliance – Braine l'Alleud, Belgium About the role The Global Quality Lead for GCP Auditing & Compliance will develop and execute a GCP audit strategy,...
-
Global Quality Lead GCP Auditing
il y a 3 semaines
Braine-l'Alleud, Wallonie, Belgique UCB Temps pleinMake your mark for patientsTo strengthen our Quality Auditing & Compliance department we are looking for a talented person to fill the position of: Global Quality Lead GCP Auditing & Compliance – Braine l'Alleud, Belgium About the role The Global Quality Lead for GCP Auditing & Compliance will develop and execute a GCP audit strategy, delivering a...
-
Global Quality Lead GCP Auditing
il y a 1 semaine
Braine-l'Alleud, Wallonie, Belgique UCB Temps pleinMake your mark for patientsTo strengthen our Quality Auditing & Compliance department we are looking for a talented person to fill the position of: Global Quality Lead GCP Auditing & Compliance – Braine l'Alleud, Belgium About the role The Global Quality Lead for GCP Auditing & Compliance will develop and execute a GCP audit strategy, delivering a...
-
Global Quality Lead GCP Auditing
il y a 3 semaines
Braine-l'Alleud, Wallonie, Belgique UCB Temps pleinMake your mark for patientsTo strengthen our Quality Auditing & Compliance department we are looking for a talented person to fill the position of: Global Quality Lead GCP Auditing & Compliance – Braine l'Alleud, Belgium About the role The Global Quality Lead for GCP Auditing & Compliance will develop and execute a GCP audit strategy, delivering a...
-
Vendor Quality Lead
il y a 1 semaine
Braine-l'Alleud, Wallonie, Belgique UCB Temps pleinMake 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...
-
Global Quality Lead Gvp Audit Compliance
il y a 1 semaine
Braine-l'Alleud, Wallonie, Belgique UCB S.A. Temps pleinMake 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...
-
Clinical Quality Lead
il y a 1 semaine
Braine-l'Alleud, Wallonie, Belgique UCB Temps pleinMake 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...
-
Clinical Quality Lead
il y a 3 semaines
Braine-l'Alleud, Wallonie, Belgique UCB Temps pleinMake 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 3 semaines
Braine-l'Alleud, Wallonie, Belgique UCB Temps pleinMake 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 pleinMake 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 pleinMake 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 Support
il y a 1 semaine
Braine-l'Alleud, Wallonie, Belgique Jefferson Wells Temps pleinLocation:Braine L'Alleud#23107Global Quality Lead SupportBrabant Wallon - contractingOur 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 provides support to a Global...
-
Vendor Quality Lead
il y a 1 semaine
Braine-l'Alleud, Wallonie, Belgique UCB Temps pleinMake 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...
-
Global Quality Lead Solutions Partner
il y a 1 semaine
Braine-l'Alleud, Wallonie, Belgique Jefferson Wells Temps pleinLocation:Braine-l'Alleud#24297Global Quality Lead Solutions Partner:Brabant Wallon - contractingOur 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.What are your responsibilities?: Product Change Control...
-
Global Products Quality Solutions Head
il y a 1 semaine
Braine-l'Alleud, Wallonie, Belgique UCB Temps pleinMake your mark for patientsTo strengthen our Global Products Quality Management department, we are looking for a talented professional to fill the position of:Global Products Quality Solutions Lead - Braine l'Alleud, BelgiumAbout the roleReporting to the Head of Global Quality Leads, this role in Global Quality Organization provides leadership and GMP...
-
Global Products Quality Solutions Head
il y a 23 heures
Braine-l'Alleud, Wallonie, Belgique UCB Temps pleinMake your mark for patientsTo strengthen our Global Products Quality Management department, we are looking for a talented professional to fill the position of: Global Products Quality Solutions Head – Braine l'Alleud, Belgium About the roleReporting to the Head of Global Quality Leads, this role in Global Quality Organization provides leadership and GMP...
-
Quality System Management Lead
il y a 1 semaine
Braine-l'Alleud, Wallonie, Belgique UCB Temps pleinMake your mark for patientsWe 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, Belgium.About the RoleAs the GxP and GMP/GDP Quality Management System Lead, you will be responsible for...
-
Biotech Quality Partner
Il y a 2 mois
Braine-l'Alleud, Wallonie, Belgique Randstad Temps pleinWe are looking for a Biotech Quality Partner for one of our clients based in Braine-l'Alleud.Don't hesitate to contact me : - Life Sciences Wallonie.Project contract until end December 2024.key responsibilitiesThis position closely collaborate with the Global Quality Lead (GQL) relative to Quality Assurance activities associated with the lifecycle...
-
Global Demand Management Lead
il y a 1 semaine
Braine-l'Alleud, Wallonie, Belgique UCB Temps pleinMake your mark for patientsUCB is seeking a dynamic and experienced individual to join our team as the Global Demand Planning Management Lead based in Braine, Belgium.About the roleIn this critical role, you will be responsible for leading the demand planning function globally, ensuring accurate forecasting, efficient inventory management, and optimizing...
-
Vendor Quality Lead Bio Ds, Gmp Gsp Quality
il y a 1 semaine
Braine-l'Alleud, Wallonie, Belgique UCB Temps pleinMake 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...
