Job Description
Resource Management and Training:
1. Participation in QM resource allocation
2. Resource allocation of QA auditors
3. Facilitation of professional development and career advancement of Quality Management staff
4. Administrative supervision of Quality Management staff, jointly with Senior Director Quality Management
5. Participation in recruitment of Quality Management (QM) staff
6. Facilitation of initial and ongoing training of Quality Management staff
7. Oversight of initial and ongoing training of PSI Operations employees in quality management topics
Quality Management:
8. Facilitation of regulatory agency inspections of PSI
9. Facilitation of regulatory agency inspections of PSI-managed trial sites, including follow-up
10. Participation in hosting client/third party audits of PSI, including follow-up
11. Oversight of CAPA investigations management
12. Management of investigations of suspected research misconduct, jointly with Senior Director Quality Management
13. Backup responsibility for review of draft Quality Systems Documents (QSDs), including newly developed and revised QSDs
14. Backup responsibility for approval of Quality Systems Documents
15. Oversight of vendor qualification
16. Oversight of computer systems validation documentation review
17. Oversight of the process of providing assistance and feedback to all Company staff with regards to various GXP, regulatory compliance, and other QM matters
18. May act as the primary QM contact for PSI Operations divisions and working groups/task forces with regard to various Corporate projects requiring QM
Quality Assurance Auditing:
19. Development and implementation of the annual audit plan
20. Management of QA audits contracted to PSI
21. Oversight of the preparation and maintenance of internal and contracted quality assurance audits documentation
Business Development:
22. May be recruited by Business Development for client meetings and vendor shows
Qualifications
23. College or university degree
24. MD, PharmD or degree in life sciences is a plus
25. Minimum 7 years of experience in Clinical Research
26. Minimum 5 years industry experience in the capacity of a QA auditor or equivalent
27. Must have experience in planning, conducting and reporting all types of quality assurance audits
28. Auditing experience in USA
29. Excellent knowledge of ICH GCP guidelines, FDA/ EMA regulations, and applicable local regulations
30. Team oriented with superior communication and interpersonal skills
31. Strong time management, organizational, planning and presentation skills
32. Demonstrated ability to meet tight deadlines, multi-task/be flexible and thrive in a fast-paced work environment
33. Intermediate proficiency in MS Office (Word, Excel Power Point, Outlook)
34. Must be a reasonably effective public speaker
Additional Information
All your information will be kept confidential according to EEO guidelines.