To effectively partner with Clinical Operations to lead and implement QA systems and SOPs for GCP systems and other assigned projects. Candidate must have knowledge and experience of appropriate GCP compliance and other applicable regulations and laws. Demonstrated capabilities to implement systems and perform GCP audits in accordance with AGENUS processes. To exhibit a high degree of flexibility and initiative, demonstrate the ability to follow up on multiple tasks and projects, and possess the ability to handle confidential information.
The Principal GCP QA Auditor will define and oversee GCP audit programs. This candidate will be responsible for defining the GCP audit schedule to ensure external and internal entities (including GcLP laboratories) and contract organizations meet all defined regulatory requirements.