BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description:
The Manager, Distribution & Regional Quality, Europe Quality is responsible for overseeing Good Manufacturing Practices (GMP) as well as Good Distribution Practice (GDP) operations related to the commercial products including trading in foreign countries. This position ensures compliance with EU GMP and GDP regulations on transportation, wholesale and distribution. The role ensures adherence to EU regulations, as well as BeOne's internal quality processes and procedures.
BeOne operates several affiliates in Europe and holds different GxP licenses in these affiliates. The job incumbent will execute the assigned activities on behalf of the below listed affiliates based on the license utilized.
Affiliates in scope: BeOne Medicines I GmbH, BeOne Medicines I GmbH, Dutch Branch, BeOne Medicines France Sarl, BeOne Medicines UK, Ltd and BeOne Medicines Germany GmbH
For activities performed for Switzerland under BeOne Medicines I GmbH the allowed delegations per VV-QDOC-10970 CH – Deputization and Delegation of RP Tasks within BeiGene Switzerland GmbH need to be considered.
Essential Functions of the job:
1. Trade authorization of finished products manufactured by
- contract manufacturers on behalf of BeOne
- cooperation partners of BeOne
- BeOne
2. Batch Review and EU QP batch certification preparation: Batch review and release preparation for commercial APIs, primary packed products and finished products manufactured by BeOne or contract manufacturers on behalf of BeOne.
3. Perform customer and wholesaler approval
4. Deviation (incl. Temperature Excursion), CAPA and Change Control Management
5. Complaint Management (distribution complaints and market complaints)
6. Prepare, manage and maintain documentation and reports required to support and improve the execution of Regional Quality activities
7. Conduct GDP releases post QP batch certification
8. Ensure Inspection readiness within area of responsibility
9. Support Health Authority Inspections and Audits as needed.
10. Support launch of new products in a country
11. Quality representative in SAP Project for local affiliate
12. Support and work with in-country wholesalers and distributors/3PLs
13. Support Quality Oversight of GDP operations and compliance
14. Support the implementation of Quality requirements within the Distribution scope
15. Support the customer product returns process and evaluation of the product for use
16. Support the establishment/update of Quality Agreements with local 3PLs / distributors / wholesalers
17. Assist with preparation and provision of Key Performance Indicator metrics
18. This is a hands-on position
Education Required:
19. Min 5+ years of relevant experience in Distribution Quality in pharmaceutical industry with a Bachelors degree.
20. Solid foundation in QA and understanding of product distribution quality requirements.
Computer Skills:
21. PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint), Veeva, SAP
22. Ability to work on a computer for extended periods of time
Core Knowledge and Skill Requirements:
23. EU GMP experience
24. EU GDP experience
25. Fluent in English
26. Fluent in German is a plus
Other Qualifications:
27. Very good interpersonal skills, including listening, writing, negotiations, facilitations, attention to detail.
Travel:
28. Max 10 %
Salary Range Switzerland: 109,500.00 CHF - 136,900.00 CHF
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
29. Fosters Teamwork
30. Provides and Solicits Honest and Actionable Feedback
31. Self-Awareness
32. Acts Inclusively
33. Demonstrates Initiative
34. Entrepreneurial Mindset
35. Continuous Learning
36. Embraces Change
37. Results-Oriented
38. Analytical Thinking/Data Analysis
39. Financial Excellence
40. Communicates with Clarity