Sr. Director Clinical Quality
Princeton, New Jersey
A rapidly expanding pharma company is seeking a Sr. Director Clinical Quality to join its rapidly expanding team. This role was created to help the organization gear up for an upcoming inspection to determine if its leading drug candidate will be commercialized. This organization has hundreds of millions of dollars in revenue from a product already on the market all while maintaining a small start-up feel. This is a critical time to join this organization as it is on track for another phase of accelerated growth all while providing the stability of having one successful drug on the market. If interested in learning more, don't hesitate to apply!
The Sr. Director Clinical Quality will have the following responsibilities:
- Lead cross functional training on GCP/GLP/GVP principals to ensure inspection readiness.
- Implementation of quality standards across other areas that provide input into the QMS such as clinical research, medical affairs commercial, etc.
- Contribute to the management of the company's R&D quality system while driving continuous improvement efforts.
- Notify senior management of significant deficiencies/deviations in quality and compliance standards and ensures CAPAs are implemented
The ideal candidate will have the following skill set:
- Bachelor's degree in Life Sciences.
- A minimum of 10 years' experience in pharmaceutical or biopharmaceutical industry with increased responsibilities related to GCP and GLP or GVP Quality.
- A minimum of 5 years in a leadership role