Senior GCP Process Auditor

Precision for Medicine is a Clinical Research Organisation. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry‑leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.

As our company continues to grow, we are seeking a GCP Process Auditor to join our team.

As a Process Auditor, you will support the audit program and clinical projects to ensure compliance with regulations and Precision procedures. You will be responsible for providing oversight and subject matter expertise to quality and compliance activities, supporting project teams during all stages of a clinical study.

Essential functions of the job include but are not limited to:

• 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

Who we are seeking:

• The ideal candidate will have extensive, working knowledge of managing all types of Audits, particularly GCP Process Audits - candidates without this experience cannot, unfortunately, be considered
• 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

Preferred:

• CRO experience
• QA certification preferred (e.g., CQA, SQA, etc.)
• Experience with electronic clinical trial systems (e.g., EDC, CTMS, IxRS, ePRO, etc.)

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at