GCP Auditor

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Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $35.2M Venture Round on 2021-03

Biotechnology • Healthcare Insurance • Pharmaceuticals

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 Description

• Support the quality management system including SOPs, training, and CAPA • Process and maintain documentation for controlled documents • Develop and administer training for employees and/or consultants • Host client/sponsor audits and support regulatory inspections • Coordinate and conduct assessments of potential vendors including vendor audits • Conduct internal audits of quality systems • Conduct investigator site audits • Conduct trial master file audits • Participate in computer systems validation projects • Provide QA consultation and support to assigned project teams • Manage reported quality issues and associated corrective and preventive actions • Monitor quality systems to provide feedback on compliance risks and identify opportunities for improvement

🎯 Requirements

• Extensive knowledge of managing audits in clinical trials environment • Working knowledge of GCP/ICH guidelines and FDA regulations • Bachelor’s degree in a science, healthcare, or related field of study • Availability to travel up to 25% domestically and/or internationally • 2 or more years’ experience in QA GCP department in a related industry preferred • QA certification preferred (e.g., CQA, SQA, etc.) • Experience with electronic clinical trial systems (e.g., EDC, CTMS, IxRS, ePRO, etc.)

🏖️ Benefits

• Help shape the quality management system • Attend training sessions • Work from home • Opportunities in high-impact clinical trial areas