What are the responsibilities and job description for the Director, Clinical Quality Assurance position at Corbus Pharmaceuticals?
The Director of Clinical Quality Assurance will oversee all aspects of quality assurance focused on Good Clinical Practice (GCP) activities to ensure compliance with regulations, guidelines, and company standards.
- Establish and maintain quality programs and documentation to assure GCP compliance and inspection readiness.
- Collaborate with the internal clinical operations team to ensure compliance standards are achieved.
- Manage the GCP quality interface and support for all clinical project teams.
- Identify and mitigate compliance risks.
This role requires a scientific or engineering degree and 12 years of experience in the GxP biotechnology/pharmaceutical industry. The ideal candidate will have knowledge of GCP regulations, effective communication skills, and ability to influence and work effectively with business partners.
Candidates must be well-organized, detail-oriented, and able to prioritize work effectively. They should also have advanced word processing, data entry, and data presentation computer skills.
A self-starter and team player who thrives in a fast-paced dynamic environment is desired. Proficiency in using Veeva and Microsoft Office applications is required.
Corbus is an equal opportunity employer and offers a welcoming space where collaboration, mentorship, and diversity are encouraged.