Make your mark for patients
To strengthen our Chemistry, Manufacturing and Controls team, we are looking for a talented and motivated individual to fill the position of: CMC Development Learning Partner – Braine L’Alleud.
About the role :
The CMC Development Learning Partner staff qualifications meet compliance standards, oversees training strategies and execution, and drives continuous improvement in training management and business processes.
Your activities :
1. Oversee staff qualifications to ensure compliance within CMC development (create/update training matrix and training plan)
2. Enhance training for all CMC
3. Develop and provide KPIs, metrics, reports on training achievements
4. Communicate training availability within CMC and other departments
5. Lead cross-functional meetings with stakeholders for business processes
6. Support change controls involving organizational or staff qualification processes and systems
7. Ensure inspection readiness for all activities in scope
8. Identify opportunities to simplify compliance processes and systems with the process excellence team and stakeholders
9. Escalate critical issues to senior management when necessary
10. Manage issues, risks, problem-solving and solutions
Interested ? For this position, you must have the following training, experience and skills :
11. Bachelor’s degree
12. At least 5 years of experience in pharmaceutical development, preferably in compliance or training management
13. Knowledge of Quality Management Systems applied to CMC development, with a deep understanding of GxP processes and systems (good manufacturing practices, good storage practices, etc.)
14. Experience in preparing business process audits
15. Thorough knowledge of learning principles and associated tools
16. Ability to build partnerships internally and externally
17. Effective leadership, collaboration mindset, and communication skills
18. Resilience and ability to lead and influence people
19. Excellent planning and organizational skills
20. Project management skills
21. French and English: written and spoken
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!