Make your mark for patients
To strengthen our Research & Development and Pharmacovigilance Quality we are looking for a talented profile to fill the position of: R&D and PV Quality Project Lead – Braine l’Alleud, Belgium.
About the role
The R&D and PV Quality Project Lead, in synergy with the Project Owner in R&D and PV Quality, will engage in strategic initiatives and projects that support the Quality Strategy and R&D and Pharmacovigilance Quality objectives. The position will primarily lead/support the transition of strategic growth objectives and priorities into actionable project plans and ensure projects are planned, executed, and monitored in alignment with defined targets to demonstrate measurable value, consistent with the required quality and compliance standards.
You will work with
As R&D and PV Quality Project Lead you will work in strong partnership with the R&D and PV Strategy Lead, to whom you will directly report and in close synergy with the Project Owner in R&D and PV Quality to drive strategic quality initiatives. You will also closely engage with subject matter experts within the R&D and Pharmacovigilance Quality teams to support project execution, impact assessments, and compliance activities. In addition, as Project Lead you will collaborate with the Regulatory Intelligence Network (RIN), coordinating the review and assessment of new or updated GLP, GCP, and GVP legislation, and liaising with internal experts and relevant stakeholders to ensure regulatory changes are assessed, implemented, and closed in alignment with UCB and vendor quality processes.
What you will do
Project Management
1. Ensures projects are aligned with R&D and PV strategic goals and objectives and ensures alignment with R&D and PV Quality LT, the Project Owner (PO) in RDPVQ, project sponsors and stakeholders SME.
2. Partner with the PO in R&D and PV Quality, and other functions, to initiate, plan, execute, monitor, and close projects ensuring delivery and measurable impact.
3. Drive project activities with respect to communication (change management), resources, cost and timelines.
4. Collaborate with R&D and PV Quality team members to ensure successful and sustainable project deliverables within day-to-day work.
5. Facilitate interaction with UCB PMO (Project Management Office) on projects assigned in alignment with UCB standards.
Strategic Planning
6. Support R&D and PV LT to translate R&D and PV Quality strategy and objectives into actionable operational projects.
7. Develop and maintain project roadmaps, timelines, and resource plans when impacting R&D and PV Quality
8. Strategic performance management, i.e. roadmap development and measurement of impact
Clinical Quality Assessment Reports (CQAR)
9. Support the development and implementation of processes, template relative to and the delivery of Product-specific Clinical Quality Assessment Reports aimed at ensuring and providing an overview on quality and compliance across a product’s development lifecycle, in support of the designated Quality Lead.
Regulatory Oversight
10. In alignment with Regulatory Intelligence Network (RIN) Quality process, maintain a central overview of global GLP/GCP and GVP relevant legislation, guidance and updates
11. Coordinate for R&D and PV Quality the review and assessment of new or updated legislation, including the assignment of relevant R&D and PV Quality experts.
12. Follow-up on the impact assessment on UCB and Vendor processes via the assigned SMEs in R&D and PV Quality, until closure. Report progress to relevant SMEs, the Head of R&D and PV Quality and the R&D and PV Quality Leadership Team.
13. Represent R&D and PV Quality in the Regulatory Intelligence Network (RIN) within Quality.
14. Integrate GLP, GCP and GPvP compliance requirements into project activities impacting R&D and PV areas and ensure adherence to internal procedures.
Stakeholder Management
15. Build and maintain strong relationship across Quality and relevant Business Stakeholders.
16. Ensure a project communication plan is in place, to identify communication deliverables,, audiences, interfaces, timings, and mechanisms for effective and collaborative communication to the organization.
17. Build/Maintain Project Management Tools and Guidance and support all in R&D and PV Quality through coaching and sharing of best practices.
External Audit/ Health Authority Inspection Management
18. Support GLP/GCP/HTA/GPvP inspections and investigations conducted by international and national authorities or business partners according to UCB Policies and Procedures per the area of responsibility and as assigned
Resource Management
19. In support of the Head of R&D and PV Quality, facilitate regular resource planning review meetings with the R&D and PV Quality LT, coordinate updates from the R&D and PV Leadership Team and the maintenance of documentation.
20. Analyse timecards for R&D and PV Quality, compare with resource projects, and share conclusions with the Head of R&D and PV Quality and LT regularly.
21. Maintain the R&D and PV Quality Team meta-data master file to incorporate information requested from/provided by the R&D and PV Leadership Team in a timely manner.
Interested? For this position you’ll need the following education, experience and skills
22. Bachelor's Degree required; master’s degree preferred in Life Sciences or engineering related field.
23. Prior experience in Pharmaceutical Research & Development (sponsor or CRO) is required with preferably 10 years total experience in one or more of the following areas: pharmaceutical /biotechnology industry, with mandatory experience in R&D and/or R&D Quality.
24. Solid experience and track record in success Project Management in complex, cross-functional environment - qualification in Project Management/Project Leadership preferred
25. Fluent English communication (oral and written); any additional languages are a plus.
26. Practical experience in applying operational excellence methodologies (Lean, Six sigma, Agile, Continuous Improvement).
27. Proven track record in operational excellence and (digital) transformation initiatives.
28. Ability to analyses intermediate/complex level problems, collaborates with others to develop innovative ideas and solutions, and evaluates the impact of proposed solutions.
29. Proficient in root cause analysis and ability to proactively identify, assess, mitigate and manage potential risks
30. Experience in data driven decision making and performance management.
31. Demonstrated self-starter, highly reliable, with positive, enthusiastic approach, ability to manage own workload, set priorities within the remit allocated by management and willingness to accept responsibility.
32. Knowledge and understanding in GxP regulations and guidelines (GLP, GCP, GVP).
33. Foster a quality culture of shared accountability and knowledge sharing through inspiring, motivating, influencing, teaching and coaching others both within and outside the team.
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!