- You will assure distribution compliance using best practices in Risk Management by :Complying with GDP regulationsDeveloping and safeguard relevant procedures and internal controlsSpreading and deploy methods to proactively manage risk
- You will serve patient needs by :Providing a rapid response to distribution compliance related supply interruptionsStrategizing for innovation to facilitate delivery and increase speed
- You will protect the company reputation by :Building awareness to integrate GREEN into our logistics/distribution operationsHelping deliver on the UCB GREEN objectivesProjecting UCB 's company reputation to ensure access to the best opportunities that can help serve patients' needs
- You will drive business value by:Adopting a continuous improvement mindset
- You will act as subject matter expert (SME) for documenting "shipping qualification" protocols and reports in reference with thermal and mechanical aspects for packaging systems used within logistics.
- You will establish these governances and processes in coordination with Distribution process architect and Distribution master data steward.
- You will provide SME support and training to key stakeholders including markets, CMO's, Quality teams etc.
- You will be responsible for maintaining the technical shipping qualification matrix and the framework of distribution processes.
- You will drive cost improvement of shipping systems and implement new shipping systems solutions in relation with the business needs.
- You will ensure audit readiness including GDP inspection (MHRA, FDA, country specific ANVISA,...) and internal and external audit (Customers, Corporate,...) readiness at all times and act as SME during these inspections and audits.
- You will establish, define and maintain shipping qualification and shipping risk analysis processes that meet current standards and guidance (Good Distribution practice, Good documentation practice, ISPE cold chain management, process qualification standard and guidance, regulatory requirement)
- You will set up and maintain standard templates of shipping qualification test protocols and test reports in accordance with the relevant regulation (URS, OQ, PQ).
- As SME, you will participate actively to the elaboration and the maintenance of the RA CMC file template (section 3) and assure the uniformity and coherence for new products submission.
- You will drive and lead the relevant regulatory requirements (GDP, USP, ASTM, ISO, ....) into a global strategy for Cold Chain management within UCB.
- You understand basics of supply chain flow & concepts from long term demand to distribution to the patients (tools, terminology and techniques).
- You understand the importance of accurate and comprehensive master data and GxP rules. At ease using IT tools used in supply chain.
- You have a working knowledge of GMP/GDP regulations, implementing procedural control frameworks, and experience with audit/inspection protocols.
- You have the ability to manage the "grey zone", balance multiple priorities
- You are able to work without direct supervision; able to work under pressure and within an international team environment
- You have both analytic and synthetic approaches to identify optimal solutions to complex system problems.
- You are self-directed in defining a problem, identifying root cause & correlations, defining solutions and selecting the most appropriate, and checking the effectiveness of the solution post-implementation
-
senior product manager, senior manager of compliance
Gevonden in: Talent BE 2 C2 - 2 uur geleden
Brussels Airport Company Brussels, BelgiëBe part of our beating heart Brussels Airport wil bekend staan als een van de beste luchthavens ter wereld, een volledig verbonden economische hub voor mensen en bedrijven, het kloppende hart van Europa, waar klanten, innovatie en duurzaamheid centraal staan. Wil jij de luchthave ...
-
Compliance Manager
Gevonden in: Talent BE C2 - 1 uur geleden
bpost Brussels, BelgiëContext · bpostgroup is always on the move. As a leading postal operator in Belgium and an international provider of parcels and e-commerce logistics, we create real connections between millions of people, businesses and communities. Our team of +34,000 employees is our greates ...
-
DORA Compliance Program Manager
Gevonden in: Talent BE C2 - 3 dagen geleden
Resillion Brussels, België VoltijdVacatureomschrijvingDORA Expertise & Risicoanalyse: Je gaat DORA-vereisten grondig analyseren, vertalen naar concrete compliance-strategieën, en proactief risico's identificeren en mitigeren die verband houden met niet-naleving. · Samenwerking met Belanghebbenden: Bouw sterke par ...
-
Compliance oversight manager
Gevonden in: Talent BE C2 - 1 dag geleden
Michael Page Brussels, BelgiëAs Compliance oversight manager you have the following responsibilities: · Execute first-level permanent controls, particularly focusing on compliance and credit risk, and develop action plans for process improvement. · Assist front officers in detecting suspicious transactions, ...
-
Regulatory and Compliance Manager
Gevonden in: Talent BE C2 - 4 dagen geleden
EY Machelen, BelgiëEY is the only major professional services firm with a dedicated financial services practice (EY FSO) integrated in the EMEIA region. An international team of over professionals is working across borders for our clients in the financial sector: Banking, Insurance, Payment Institu ...
-
Ethics & Compliance Manager - Europe
Gevonden in: Talent BE C2 - 4 dagen geleden
Serco Brussels, België PermanentJob Introduction · Serco is a partner of choice to the European Institutions and other International Organisations. For the past 30 years, we have been providing European and International Organisations a wide range of services including ICT services in support, infrastructure, ...
-
DORA Compliance Program Manager
Gevonden in: Talent BE C2 - 2 dagen geleden
Resillion Brussels, België VoltijdJob Description · DORA Expertise & Risk Analysis: · Thoroughly analyze the requirements of the Digital Operational Resilience Act (DORA). · Translate these requirements into concrete compliance strategies. · Proactively identify and mitigate risks associated with non-compliance. ...
-
Manager IT Governance, Risk and Compliance
Gevonden in: Talent BE C2 - 1 dag geleden
KPMG Brussel, België VoltijdPosition description · Job title · (Senior) Manager IT Governance, Risk and Compliance · Function · Advisory - Manager · Roles & Responsibilities · As our team continues to grow, we are looking for a driven (Senior) Manager. · You will develop a portfolio of clients by buildi ...
-
Compliance and Ethics Manager Europe
Gevonden in: beBee S2 BE - 1 dag geleden
Page Executive Brussels city, België VoltijdAbout Our Client Our client is a British international service company, focusing on serving government and public entities globally, operating in the following sectors: defense, health, space, justice, migration, customer services, and transport. · Job Description This role will ...
-
Manager Corporate Tax Compliance
Gevonden in: Talent BE C2 - 3 dagen geleden
EY Machelen, BelgiëAt EY, our Tax professionals are dedicated to helping clients navigate complex tax regulations and optimize their financial strategies. We provide expert guidance to businesses and individuals, ensuring they remain compliant and achieve their financial objectives in a constantly ...
-
portfolio manager
Gevonden in: Talent BE 2 C2 - 1 dag geleden
Jefferson Wells Walloon Brabant, BelgiëContracting – Braine L'alleud Our client is looking for a Portfolio Manager to join their team for a global project. This job is a key role under the Portfolio & Project Management Organization within Global Engineering and Facilities. Its goal is to secure visibility on the Glob ...
-
Portfolio Manager GPAM
Gevonden in: Talent BE 2 C2 - 10 uur geleden
Jefferson Wells Walloon Brabant, BelgiëContracting – Braine L'alleud Our client is looking for a Portfolio Manager to join their team for a global project. This job is a key role under the Portfolio & Project Management Organization within Global Engineering and Facilities. Its goal is to secure visibility on the Glob ...
-
Portfolio Manager GPAM
Gevonden in: Talent BE 2 C2 - 2 dagen geleden
Jefferson Wells Braine-l'Alleud, België VoltijdContracting – Braine L'alleud · Our client is looking for a Portfolio Manager to join their team for a global project. Job description This job is a key role under the Portfolio & Project Management Organization within Global Engineering and Facilities. Its goal is to secure visi ...
-
Equipment & Data Integrity Associate
Gevonden in: Talent BE C2 - 6 dagen geleden
UCB Braine-l'Alleud, BelgiëFaites la différence pour les patients · Afin de renforcer notre équipe Analytical Processes & Operations au sein du département Manufacturing Engineer & HSE , nous recrutons un.e Equipment & Data Integrity Associate pour notre campus de Braine-L'Alleud, Belgique. · En tan ...
-
Operations Engineer
Gevonden in: Adzuna BE C2 - 1 uur geleden
Eoly Energy Braine-l'Alleud, BelgiëEoly Energy is a leading Belgian producer of renewable energy. It was founded in 2013 and is a member of Virya Energy, a Belgian energy company that focuses on renewable energy. In recent years, Eoly Energy has developed end-to-end capabilities in the entire energy value chain. T ...
-
USP Process Technician
Gevonden in: Talent BE C2 - 1 dag geleden
UCB Braine-l'Alleud, BelgiëFaites la différence pour les patients · Nous recherchons un Upstream Process Technician dynamique et motivé pour rejoindre notre équipe du Bio Pilot Plant , situé sur notre site de Braine L'Alleud , en Belgique. · À propos du rôle · En tant que Technicien de Processus, vot ...
-
QA Downstream Manager
Gevonden in: Talent BE C2 - 5 dagen geleden
UCB Braine-l'Alleud, BelgiëMake your mark for patients · We're in search of a Quality Downstream Manager with excellent communication skills, agile and a readiness to face challenges to join our Quality Department team, based in Braine-l'Alleud, Belgium, and play a pivotal role in our brand new Biomanufac ...
-
Equipment Laboratory Valid. Associat
Gevonden in: Talent BE C2 - 3 dagen geleden
UCB Braine-l'Alleud, BelgiëMake your mark for patients · We are looking for an innovative, entrepreneurial, and analytically minded Qualification/Validation Associate to join our Site Process Validation team at our UCB Braine office in Braine-l'Alleud, Belgium. · About the role: · You will be responsibl ...
-
Production Team Leader
Gevonden in: Talent BE C2 - 1 dag geleden
PolyPeptide Braine-l'Alleud, BelgiëPolyPeptide Laboratories is a high-tech enterprise specializing in the development, manufacture and sale of therapeutically active peptides . PolyPeptide SA, Belgium, with approximately 320 employees is part of the international PolyPeptide Group with companies in Sweden, India, ...
-
Documentation Coordinator
Gevonden in: Talent BE C2 - 1 dag geleden
UCB Braine-l'Alleud, BelgiëMake your mark for patients · To strengthen our QA Systems & Continuous Improvement Team , based in Braine, Belgium, we are looking for a talented individual to fill the position of: Documentation Coordinator . · In cooperation with Braine Technical Operations (BTO) and relate ...
Distribution Compliance Manager - Braine-l'Alleud, België - UCB
Beschrijving
Make your mark for patients
We are looking for a Distribution compliance Manager to join us in our organization based in Braine-l'Alleud, Belgium.
About the role:
The position is based in the UCB laboratories and offices at the Braine-l'Alleud campus
What you will do:
For this position you'll need 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