Job Description
We are seeking an experienced QA professional to join our team as a GCP/GLP Expert. In this role, you will be responsible for ensuring compliance with Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) regulations within the organization.
Your key responsibilities will include:
- Collaborating with R&D department to implement and maintain a Quality Management System (QMS)
- Managing suppliers/subcontractors/clinical vendors and CROs, including selection, risk-based assessment, audit, approval/qualification, follow-up, periodic review/re-qualification
- Managing quality agreements and contracts covering quality requirements
Key qualifications for this role include a Bachelor's degree in a scientific or life sciences field, with at least 10 years of experience in the biotech/pharmaceutical industry in a GCP quality role, clinical monitoring, or equivalent.