Principal GCP Quality Assurance Auditor

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Requirements:

• Minimum of 5 years of experience.
• Working knowledge of GCP/ICH guidelines and FDA regulations.
• Experience conducting various audit types.
• Bachelor’s degree in a science, healthcare, or related field; equivalent experience may be accepted.
• Availability to travel up to 25% domestically and/or internationally.

Responsibilities:

• Serve as a subject matter expert for clinical project teams.
• Support the Quality Management System including SOPs, training, and CAPA.
• Attend project meetings and provide compliance guidance.
• Conduct audits and assessments of vendors and quality systems.
• Host client audits and support regulatory inspections.
• Maintain Q&C documentation and trackers.