Principal GCP Quality Assurance Auditor

November 15

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Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000

💰 $35.2M Venture Round on 2021-03

Description

• Provide senior oversight and subject matter expertise to quality and compliance activities. • Support the Q&C Management team, Q&C team members, and the project teams during all stages of a clinical study. • Serve as a subject matter expert for clinical project teams. • Review project plans and provide compliance guidance on complex issues independently. • Host client/sponsor audits and support regulatory inspections. • Monitor quality systems to provide feedback on compliance risks to QA management and identify opportunities for improvement. • Support Proposals and Bid Defense meetings as needed.

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 • Disability benefits • Parental leave • Paid time off for sick leave and vacation