|Published||7 days ago|
Director Clinical Quality Assurance, GCP (California)
Global strategy focused position with a rapidly growing and innovative biotechnology company that focuses on bringing world class critical care therapeutics to patients globally.
The Director of QA, GCP will be a key member of the Quality Leadership team. This individual will be responsible for driving an innovative new vision across the Clinical Global Quality function and ensure overall world class GCP compliance. A unique opportunity to drive change and implement practices that the company will rely upon as they continue to grow in the next 3, 5 and 10 years.
Responsible to drive a new vision and set a risk based strategy for the Global Clinical Quality Assurance function
Develop and implement SOPs and Quality System Management in respect to GCP, GLP and GPV standards
Ensure the Quality Assurance compliance of all global GCP
Conduct and oversee CRO and Investigator site monitoring, as well as inspection readiness
Manage the overall maintenance of quality levels within the Clinical QA group through establishing effective training and set expectations globally.
10 + years of strong leadership experience working in the Quality Assurance space with 5 + years of Clinical Quality Assurance, GCP focus.
Bachelor Degree with a preferred Master's degree or equivalent
5+ years of management experience in the Quality space, as well as experience expanding/building Quality teams
Must have strong knowledge of GCP regulations and preferably GLP, GPV compliance as well