Senior GCP Process 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 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, 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 • Maintain 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

• Health insurance • Professional development opportunities