Head of External Clinical Supply Quality, Jefferson Wells
il y a 3 semaines
Contracting – Brabant Wallon Operational Provide timely and efficient GMP/GDP IMP Release function to all relevant project activities related to the development of the pipeline projects (included all relevant activities for IMP release: label approval, batch record documentation, etc…). Support compliance with all relevant and appropriate regulations and guidelines, such as those relating to GMP/GDP, health and safety, etc. Participate in the management of QA through active participation in QA forums and other meetings. Support in-licensing activities by providing Quality Assurance expertise for the evaluation of new project opportunities including participation in due diligence activities. Support the systems and processes in place for the appropriate documentation of the company development activities and to maintain them in a manner compliant with regulatory and corporate requirements. Ensure the Clinical Supply Quality activities are consistent across the range of different environments and teams supported (Vendors / Suppliers / in house). Proactively support the activities of Clinical supply for relevant manufacturing quality systems (deviation close out / Change management / complaints / quality improvement). Identify and facilitate resolution of technical and manufacturing quality issues that may impact the quality of the CMC sections of regulatory submissions. Provide support in the evaluation of Temperature excursions for IMP. Management of Quality Complaints of IMP Participate in/coordinate escalation of quality topics linked to IMPs supplies Ensure active participation in the selection, evaluation, approval and maintenance of Vendors for IMP activities, including leadership or support to conduct appropriate audits. Oversight of Distribution activities (deviations, Business Review Meetings, assessments, etc…) Ensure CMO (packaging and distribution vendors) quality documentation is accurate and up-to-date, by editing and reviewing quality agreements Contribute the preparation of audits (internal/external, regulatory inspections) Lead internal audits / Self-Inspections Process Ensure that all review and release, manufacturing and packaging operations are appropriately compliant with applicable regulations (EMEA, FDA, DEA, MHRA, etc. where relevant). Support the Head of Clinical Supply Quality in ensuring an acceptable outcome of all audits and inspections, especially those by government agencies, as they pertain to Process Support and Package Development practices (where relevant), equipment, and facilities. Actively participate in identifying, developing and implementing local quality and operational excellence improvements in response to business requirements, technical changes and regulatory requirements by encouraging others to seek opportunities for different and innovative approaches to addressing problems and developing solutions. Ensure Clinical Supply Quality processes directly support Technical Operations and development partner goals and objectives. Review and QA approval of deviations, change controls and complaints. Team Ensure Staff are managed appropriately, have clearly defined roles, are appraised on an annual basis, have clear objectives, work in accordance with HSE and corporate policy requirements and are developed and trained to meet the need of the business and professional career development. Oversee resolution of staff-related performance issues. #J-18808-Ljbffr
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Head of External Clinical Supply Quality
il y a 3 semaines
Braine-l'Alleud, Belgique CareerWallet Temps pleinContracting – Brabant Wallon Operational Provide timely and efficient GMP/GDP IMP Release function to all relevant project activities related to the development of the pipeline projects (included all relevant activities for IMP release: label approval, batch record documentation, etc…). Support compliance with all relevant and appropriate regulations and...
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Clinical Supply Vendor Quality Lead
il y a 3 jours
Braine-l'Alleud, Belgique WhatJobs Temps pleinUCB Braine-l’Alleud, Walloon Region, Belgium Clinical Supply Vendor Quality Lead – Braine l’Alleud, Belgium To strengthen our Clinical Supply Quality department, we are looking for a talented profile to fill the position of: Clinical Supply Vendor Quality Lead – Braine l’Alleud, Belgium. About the Role As a member of the Clinical Supply Quality...
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Complaints and Escalation Management Quality Lead
il y a 5 jours
Braine-l'Alleud, Belgique Jefferson Wells Belgium Temps pleinComplaint and Escalation Management Quality LeadContracting – Brabant WallonYour responsibilities:Corporate Escalation Process:Take ownership as GMP Corporate Process Owner (CPO) of the Escalation Management Process. Owns the Global documentation and training in English linked to the process and associated processes.Build strong, collaborative...
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Complaints and Escalation Management Quality Lead
il y a 3 jours
Braine-l'Alleud, Belgique Jefferson Wells Belgium Temps pleinComplaint and Escalation Management Quality LeadContracting – Brabant WallonYour responsibilities:Corporate Escalation Process:Take ownership as GMP Corporate Process Owner (CPO) of the Escalation Management Process. Owns the Global documentation and training in English linked to the process and associated processes.Build strong, collaborative...
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Complaints and Escalation Management Quality Lead
il y a 3 jours
Braine-l'Alleud, Belgique Jefferson Wells Belgium Temps pleinComplaint and Escalation Management Quality LeadContracting – Brabant WallonYour responsibilities:Corporate Escalation Process:Take ownership as GMP Corporate Process Owner (CPO) of the Escalation Management Process. Owns the Global documentation and training in English linked to the process and associated processes.Build strong, collaborative...
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Complaints and Escalation Management Quality Lead
il y a 3 jours
Braine-l'Alleud, Belgique Jefferson Wells Belgium Temps pleinComplaint and Escalation Management Quality Lead Contracting – Brabant Wallon Your responsibilities: Corporate Escalation Process: Take ownership as GMP Corporate Process Owner (CPO) of the Escalation Management Process. Owns the Global documentation and training in English linked to the process and associated processes. Build strong, collaborative...
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Product Planner
il y a 4 heures
Braine-l'Alleud, Belgique Jefferson Wells Temps pleinLocation: **Braine l'Alleud** - Type: **Contracting** **#20698** **Product Planner**: Brabant Wallon - contracting Our partner is looking for a **Product Planner** to join its team. This international company is well-known for its pharmaceuticals and vaccines. **What are your responsibilities?**: You will ensure products availability on markets and you...
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Head of Global Quality Auditing Gcp
il y a 5 heures
Braine-l'Alleud, Belgique UCB Temps plein**Make your mark for patients** To strengthen our **Global Quality Assurance **department, we are looking for a talented profile to fill the position of**:Head of Global Quality Auditing GCP & GLP - Braine l’Alleud, Belgium** **About the role** This Quality Leadership role at UCB involves developing and implementing a global quality auditing strategy...
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Clinical Supply Partnering Business Lead
il y a 2 semaines
Braine-l'Alleud, Belgique UCB Temps pleinMake your mark for patientsWe are looking for a Clinical Supply Partnering Business Lead who is strategic, collaborative, and solution-oriented to join our Development and Clinical Supply team, based at our UCB campus located in Braine-l'Alleud, Belgium.About the roleYou’re going to lead the development of sustainable and agile partnerships...
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Clinical Supply Planner
il y a 2 semaines
Braine-l'Alleud, Belgique UCB S.A. Temps plein**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 backgrounds and experiences - not just the best and brightest, but those who care...
