GCP Auditor

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Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $75M Private Equity Round on 2015-12

Biotechnology • Healthcare Insurance • Pharmaceuticals

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• Support the audit program and clinical projects to ensure compliance with applicable regulations and Precision procedures • Provide oversight and subject matter expertise to quality and compliance activities • Support project teams during all stages of a clinical study • 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 and contracted vendors, including vendor audits • Coordinate and conduct internal audits of quality systems • Coordinate and conduct investigator site audits • Coordinate and conduct trial master file audits • Participate on computer systems validation projects • Provide QA consultation and support to assigned project teams • Support and manage reported quality issues and any associated corrective and preventive actions • Monitor quality systems to provide feedback on compliance risks to QA management

🎯 Requirements

• Extensive, working knowledge of managing audits in Clinical Trials environment • Working knowledge of GCP/ICH guidelines and FDA regulations and standards • 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

• Flexible work arrangements • Professional development opportunities