Make your mark for patients
To strengthen our Clinical Supply Quality department we are looking for a talented profile to fill the position of: Clinical Supply QP Partner - Braine l’Alleud, Belgium.
About the role
As Qualified Person for IMP batch release, the Clinical Supply QP Partner acts as QP according to current regulation for Investigational Medicinal Products and is responsible for the management of batch disposition and release activities concerning the provision of IMP for UCB sponsored Clinical Trials. You will also act as Responsible Person, as per definition in the Good Distribution Practices.
As a member of the Clinical Supply Quality team, as Clinical Supply QP Partner you will responsible for, but not limited to the review of IMP batch records, ensuring the prompt resolution of all batch manufacturing issues and ensuring close out of development related CAPAs. This role provides direct partner driven, pragmatic and proactive support for development manufacturing.
You will work with
In this role, you will collaborate closely with the Clinical Supply Chain team, acting as the primary Quality Assurance liaison to ensure alignment and compliance across activities. You will also work in partnership with Regulatory Affairs to support regulatory requirements and submissions, while maintaining strong and continuous interaction with other Quality Assurance teams to ensure consistency, knowledge sharing, and best
What you will do
Operational
1. Ensure the manufacture, certification and distribution of Investigational Medicinal Products, is according to:
2. EC GMP guidelines (EudraLex - The Rules Governing Medicinal Products in the European Union, volume 4 – last edition)
3. Clinical Trials Regulation EU No 536/2014 and associated documents
4. Principe of Good Distribution Practices as required in EC Directive 2013/C68/01
5. Provide timely and efficient GMP/GDP IMP Release function to all relevant UCB project activities related to the development of the pipeline projects (included all relevant activities for IMP release: batch record documentation, etc…).
6. Support compliance with all relevant and appropriate regulations and guidelines, such as those relating to GMP/GDP, health and safety, etc.
7. Support in-licensing activities by providing Quality Assurance expertise for the evaluation of new project opportunities including participation in due diligence activities.
8. Ensure the Clinical Supply Quality activities are consistent across the range of different environments and teams supported (Vendors / Suppliers / in house).
9. Proactively support the activities of Clinical supply for relevant manufacturing quality systems (deviation close out / Change management / complaints / quality improvement).
10. Identify and facilitate resolution of technical and manufacturing quality issues that may impact the quality of the CMC sections of regulatory submissions.
11. Provide support in the evaluation of Temperature excursions for IMP.
12. Contribute the preparation of audits (internal/external, regulatory inspections)
13. Lead internal audits / Self-Inspections
Process
14. 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.
15. 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.
16. Ensure Clinical supply Quality processes directly support Technical Operations and development partner goals and objectives.
17. Review and QA approval of deviations, change controls and complaints.
Interested? For this position you’ll need the following education, experience and skills
18. Bachelor’s, master’s degree or an education in a relevant scientific discipline
19. Fluent English communication (oral and written); any additional languages are a plus.
20. Qualified Person (QP) Belgium number
21. Good knowledge of cGMP and relevant regulatory requirements (e.g US, European, Japanese)
22. At least 5 years’ experience in QA/compliance experience in pharmaceutical regulated environment
23. Function effectively with minimal supervision
24. Good teamwork and project management skills. Must have strong, organization and analytical skills.
25. Fact based decision maker: understand complex issues and have the ability to contribute to informed decision making when working on “grey” issues
26. Able to make/influence quality/compliance decisions in a CMC development environment.
27. Experience of participation in failure investigations
28. Familiarity with risk analysis techniques
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!