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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

  • You will assure distribution compliance using best practices in Risk Management by :
  • Complying with GDP regulations
  • Developing and safeguard relevant procedures and internal controls
  • Spreading and deploy methods to proactively manage risk
  • You will serve patient needs by :
  • Providing a rapid response to distribution compliance related supply interruptions
  • Strategizing for innovation to facilitate delivery and increase speed
  • You will protect the company reputation by :
  • Building awareness to integrate GREEN into our logistics/distribution operations
  • Helping deliver on the UCB GREEN objectives
  • Projecting 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

What you will do:

  • 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.

For this position you’ll need the following education, experience and skills:

  • 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

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-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

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Confirmed 10 hours ago. Posted 30+ days ago.

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