Distribution Compliance Manager
Il y a 2 mois
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 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 mindsetWhat 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-implementationAre 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
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