BeiGene 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 GVP Quality Lead, is responsible for supporting the Director GVP Quality in implementing and maintaining a balanced, proactive, global approach to GVP Quality Assurance. This position will be primarily responsible for ensuring PV activities are conducted in accordance with applicable regulatory requirements, guidelines, laws and internally established standards, procedures and practices.
Essential Functions of the job:
1. Conduct and support quality assurance (QA) activities related to applicable PV regulatory requirements, guidelines, laws and internally established standards, procedures and practices for all phases of drug development
2. Participate and support as member of the GVP QA team to enhance performance and maintain accountability for the implementation of QA systems
3. Develop/improve and manage quality systems and processes to include:
4. Conducting/managing routine/for cause audit of vendors, partner, internal audits etc.
5. Supporting the activities related to the vendor management process training, SOPs, etc.
6. Maintaining Key QA systems, such as investigations, Significant Quality Events (SQEs), Deviations, CAPAs, Audits
7. Developing and managing Integrated Quality Management Risk plans
8. Conducting/managing review of key PV documents
9. Developing quality metrics and measures to drive assessment and continuous improvement
10. Management and review of trends and report significant investigation/deviation issues and system deficiencies to senior management, as appropriate
11. Coordinate and/or administer GCP/GVP training, as needed
12. Participate in the review of metrics (i.e. deviation, etc.) as part of Quality Management Risk approach to identify gaps, trends and the need for process improvements
13. Coordinate and support PV inspection readiness activities and contribute to regulatory health authority inspections conduct and management
14. Expert knowledge of GVP requirements
15. Superb attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environment
16. Exercise sound and balanced judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, plans and protocols for compliance
17. Strong global knowledge and understanding of international PV regulations applicable to the conduct of clinical trials and pharmacovigilance operations
18. Participate and represent R&D Quality in meetings and discussions, as needed
19. Other duties as assigned
Qualifications:
20. Bachelor's degree, preferably in Science
21. Expert knowledge of GVPs and GCP requirements
22. Ability to resolve complex problems where analysis of situations or data requires an in-depth evaluation of various factors
23. Promote continuous improvements in quality systems and department infrastructure; assist with creation / revision of appropriate SOPs
24. Proven ability in driving quality process improvement initiatives
25. Strong global knowledge and understanding of international regulations applicable to the conduct of clinical trials and pharmacovigilance operations
26. Excellent English oral & written
BeiGene Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
27. Fosters Teamwork
28. Provides and Solicits Honest and Actionable Feedback
29. Self-Awareness
30. Acts Inclusively
31. Demonstrates Initiative
32. Entrepreneurial Mindset
33. Continuous Learning
34. Embraces Change
35. Results-Oriented
36. Analytical Thinking/Data Analysis
37. Financial Excellence
38. Communicates with Clarity