Description: Our client is currently seeking a Director ,Clinical Quality Assurance
The successful candidate will play a key role in ensuring compliance with Good Clinical Practice (GCP) standards across all clinical trials and programs.
This job will have the following responsibilities:
This role is accountable for the routine execution of Quality Assurance & Compliance duties related to the Company's clinical development programs, as well as overseeing the development, implementation, maintenance, and performance of the GCP Quality Assurance systems both within the company and external vendors.
Act as an integral member of the Quality Management team and work cross-functionally with Clinical and other teams.
Formulate and execute strategies and roadmaps with the company's Quality vision.
Collaborate closely with the clinical study management team and the Quality team to provide expert clinical compliance information, address identified issues, and drive continuous improvement.
Qualifications & Requirements:
Bachelor's Degree and 12+ years' experience leading clinical quality assurance OR Master's Degree or PhD and 10+ years' leading quality assurance for a pharmaceutical or biotech company. (Required)
Previous experience working in clinical operations is preferred.
Proficiency in and ability to apply GCP in accordance with US standards.
Extensive expertise in GCP regulations, quality systems, and regulatory requirements
Hands-on clinical quality experience in dosage forms designed to target the central nervous system.
Contact: arawat@judge.com
This job and many more are available through The Judge Group. Find us on the web at www.judge.com
