Principal GCP Quality Assurance Auditor

Description: • Precision for Medicine is a global precision medicine clinical research services organization. • The Principal Quality Auditor provides senior oversight and subject matter expertise to quality and compliance activities. • Essential functions include serving as a subject matter expert and supporting project teams during all stages of clinical studies. Requirements: • 5 years of experience • Working knowledge of GCP/ICH guidelines and FDA regulations and standards • Audit experience conducting a variety of audit types, including internal systems, vendors, TMF and investigator site audits. • Bachelor’s degree in a science, healthcare, or related field of study; combination of qualifications and equivalent relevant experience may be accepted as an alternative • Availability to travel up to 25% domestically and/or internationally • CRO, Pharmaceutical and/or Medical device experience preferred • QA certification preferred (e.g., CQA, SQA, etc.) • Experience with electronic clinical trial systems (e.g., EDC, CTMS, IxRS, ePRO, etc.) Benefits: • Discretionary annual bonus • Health insurance • Retirement savings benefits • Life insurance and disability benefits • Parental leave • Paid time off for sick leave and vacation Apply Job!