Make your mark for patients
To strengthen our Global QA for QA Operations department we are looking for a talented profile to fill the position of: QA Manager – QC Process Support – Braine l’Alleud, Belgium.
About the role
The QA Manager – QC process support provides quality expertise and ensures appropriate global oversight of Patient Supply Quality Control processes, with a primary focus on the execution of QC processes and related projects, including specifications, stability studies (protocols and reports), analytical reference standards, critical materials and standards, laboratory third parties, compendial changes and raw‑material vendor certification.
You will work with
The QA Manager – QC process support works closely with Patient Supply Quality Control teams, relevant supporting functions, and external laboratory partners and Contract Laboratory Organizations (CLOs). The role collaborates cross‑functionally to ensure compliant execution of global QC activities, effective management of QC processes such as management of critical materials and stability studies, and smooth coordination between QC, supporting services, and external partners.
What you will do
Back-up Function
1. The position can act as back-up for his direct colleagues or for his manager according to the manager’s instructions and after appropriate training
General QA Role
2. Using a Risk Based Approach, ensure that PSQC Processes & Operations are compliant with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by relevant organizations) and UCB Policies & Procedures
3. Drive quality leadership and provide technical expertise on compliance strategy.
4. Communicate processes requirements effectively across functional areas.
5. Promoting culture of quality, operational excellence and “SOSD” (See it, Own it, Solve it, Do it) attitude within Patient Supply Quality Control.
6. Deliver general cGMP training and effective coaching on QMS to relevant stakeholders.
7. Communicate compliance status and issues to appropriate organizational levels.
8. Support regulatory inspections/audits, providing dynamic assistance to SME’s.
Patient Supply Quality Control Process
9. Participate in the improvement of the PSQC processesEnsure adequate coaching and training of relevant stakeholders on the PSQC processesOversee critical global activities to ensure analytical operations are conducted in accordance with UCB Quality Standards and applicable national and/or international regulations and guidelines (EMEA, FDA, PIC/S, ICH)Ensure subcontractors supporting QC routine operations maintain adequate cGMP standardsImplement and maintain adequate Quality & Compliance indicators and communicate results to appropriate levels of the organization
Continuous Improvement
10. Identify, coordinate and support opportunities for improvement and operational excellence projects in response to business needs, technical changes, risks, audit observations and regulatory requirements.Lead or co-lead internal quality spot checks/audits to ensure compliance with internal standards and worldwide regulatory requirements with respect to cGMP.Conduct or support Quality Reviews exercises (e.g. Management/Product Reviews, etc)Identify, coordinate and support Continuous Improvement projects (LEAN, 6-Sigma, Green belt and others) with QC management to enhance quality KPI’s and product/process quality.
Interested? For this position you’ll need the following education, experience and skills
11. Bachelor’s, master’s degree or an education in a relevant scientific discipline
12. Fluent English & French communication (oral and written)
13. Strong knowledge and proven experience in Quality Control and applicable regulations
14. Proven understanding of QC processes: stability studies, material management, specification management.
15. Experience with Quality Management System and Internal/External Auditing
16. Ability to balance multiple priorities, provide leadership and prioritisation, and work with minimal supervision
17. Fact based decision maker with accountability and delivering attitude
18. Excellent team player attitude with excellent interpersonal relationship and communication skills
19. Ability to plan and direct the actions of a group of professionals and Quality Assurance personnel in multidisciplinary investigations / meetings
20. Able to perform effectively in high‑pressure situations
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!