We are working with a biopharmaceutical firm dedicated to creating innovative bi-specific and multi-specific antibodies, along with antibody-drug conjugates (ADCs), aimed at cancer treatment. The company's ultimate mission is to develop biologics that systematically target tumor microenvironments, directly combat tumors, and stimulate the immune system to fight against cancer.
Currently, the company has 8 compounds currently undergoing clinical trials, with one of which in Phase III. Also, there are 30 ongoing studies in total between US and China and they are constantly taking China studies over to US.
Responsibilities and requirements of the role:
- 10+ years of GCP QA experience
- Provide GCP strategic leadership and Subject Matter Expertise (SME) to clinical study team
- Implement and develop risk-based GCP audit strategies across clinical programs and/or studies.
- Build trainings based on key elements of the Quality System
- CAPA management
Salary Range: $260K-&280K/year
