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

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