Director, GCP QA
Looking to elevate your career to the next level with an industry leading patient-focused biopharmaceutical company? A Top-10 pharmaceutical leader that focuses on developing and manufacturing world-class innovative medicines in Neuroscience and Oncology is currently seeking a Director, GCP. This company has received recognition for their overall success and is looking to increase headcount within the Clinical Quality Department. Now is a pivotal time to get in with this group as you will have the ability to lead and impact their robust pipeline of promising new medicines.
The Director, GCP QA will have the following responsibilities:
- Provides ongoing development of the Clinical Quality Assurance (CQA) Program Managers
- Develops and implements a strategic audit plan in collaboration with R&D Global Compound Support Leaders.
- Develops and implements a strategic audit plan in collaboration with R&D Global Compound Support Leaders.
- Maximizes effectiveness and efficiency in the use of internal and external Compound Support resources.
- Ensures audit observation, report, and rating consistency for assigned area of responsibility.
- Ensures activities are conducted and reports written according to applicable SOPs and regulations.
- Supervises and oversee the analysis of audit program results, quality issues and investigations in order to optimize regional operations and global state of compliance.
- In collaboration with Supplier Quality QA, determines acceptability of vendors for potential use by R&D as well ongoing evaluation of the vendors overall compliance performance.
The ideal candidate will have:
- S. in related scientific field.
- Minimum 8 years of experience in the pharmaceutical or biotechnology industry with 6 years of GCP QA experience
- Minimum 5 years managing teams in a matrix team environment or managing people.