Interim Professionals on a Consent Decree Project
QualityHub provided Interim Professionals to work within the Quality Organization of a client under Consent Decree. They needed extra support due to lack of personnel on the client end. These projects were six months to over a year. The positions we filled on a temporary basis were:
- ‘Acting/Interim’ Quality Manager
- ‘Acting/Interim’ Complaints Manager
- ‘Acting/Interim’ CAPA Manager
- ‘Acting/Interim’ Sustaining Engineering Manager
Interim Professional – Quality Manager – Warning Letter Client Project
For a client under a Warning Letter we provided an ‘Acting/Interim’ Quality Manager. This person managed the day-to-day Quality organization as well as managing the efforts to address the Warning Letter and prepare for an FDA reinspection. The duration of the project was over 18 months. For this project the client was so happy with the individual they asked if he could serve as ‘Acting/Interim’ VP of Quality.
Interim Professional – Senior Advisor Warning Letter Client Project
For a client under several Warning Letters we provided an individual who provided two specific scopes of work over a 12-month duration:
- ‘Acting/Interim’ Quality Management System Senior Advisor who served as the corporate-level Project Architect for a company-wide Risk Management program
- Served as Coach to an incoming Corporate Quality VP
Interim Professional – Audit Program Manager
For a Medical Device client we provided an individual who served for over six months as the ‘Acting/Interim’ Internal Audit Program Manager. This individual also performed several audits in numerous countries while serving in this capacity.