Manager QA Validation – Oversight
| Company | Regeneron Pharmaceuticals |
|---|---|
| Location | Albany, NY, USA |
| Salary | $106400 – $173400 |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior |
Requirements
- Bachelor’s degree in Engineering, Chemistry, or Life Sciences
- Minimum of 7 years of direct experience in validation of pharmaceutical or biopharmaceutical facilities and processes
- Validation experience in a GMP environment
Responsibilities
- Designing and developing policies related to validation and ensuring that they are effectively administered and align with regulatory requirements
- Being responsible for all aspects of QA Validation including review and approval of documents relating to area functions
- Leading Validation team by developing validation work plans, establishing objectives, and assigning tasks
- Developing and managing validation budget, contracts, and schedules
- Presenting/defending validation data to FDA and other regulatory agencies
- Maintaining validation document and software control system while ensuring that validation status is maintained for equipment and software use in commercial and clinical manufacturing
- Organizing QA Validation resource assigned to functional area to meet goals and timings; coordinating prioritization of activities with area management
- Interacting with senior managers and executives to create a broad-based validation program
Preferred Qualifications
- Build and maintain strong working relationships across the business and with external partners, while providing exceptional customer service
- Have a continuous improvement mentality to identify and implement improvement opportunities
- Have supervisory/leadership experience