Senior GCP Process 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, as required • 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 as warranted • 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 and systems change control process • Provide QA consultation and support to assigned project teams internally and externally • 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 and identify opportunities for improvement • Maintains Q&C trackers, databases, metrics, and files • Follow applicable regulations and standards, including but not limited to local regulations (US FDA and EU), ICH and company policies and procedures

🎯 Requirements

• Extensive, working knowledge of managing all types of Audits, particularly GCP Process Audits • Working knowledge of GCP/ICH guidelines and FDA regulations and standards • 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 experience preferred • QA certification preferred (e.g., CQA, SQA, etc.) • Experience with electronic clinical trial systems (e.g., EDC, CTMS, IxRS, ePRO, etc.)

🏖️ Benefits

• Professional development opportunities • Flexible working hours