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.
Bachelors 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 Now
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.
Bachelors 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 Now