Precision for Medicine is a global 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 full – time GCP Auditor to join our team. This position is offered fully remote.
As a GCP Auditor, you will support the audit program and clinical projects to ensure compliance with applicable 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 audits in Clinical Trials environment: routine GCP audits, CRO process audits, Vendor 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
Preferred:
2 or more years’ experience in QA GCP department in a related industry
QA certification preferred (e.g., CQA, SQA, etc.)
Experience with electronic clinical trial systems (e.g., EDC, CTMS, IxRS, ePRO, etc.) We invite you to learn more about our growing organization serving our clients that are researching groundbreaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.
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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 myHR@precisionmedicinegrp.com.
Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at myHR@precisionmedicinegrp.com so we can investigate and take appropriate action.
Precision Medicine Group is a diversified organization operating in the clinical research and pharmaceutical marketing sectors. The company includes Precision AQ, a leading payer marketing agency that supports global pharmaceutical and life sciences clients in achieving commercial excellence by developing marketing strategies and communication programs for healthcare payers. Precision for Medicine is a Contract Research Organization (CRO) specializing in clinical trial management with a focus on oncology and rare diseases, offering clinical research associate services with an emphasis on employee retention and quality of life. The organization's integrated approach combines novel clinical trial designs, operational and medical expertise, advanced biomarker and data analytics solutions, and a commitment to precision medicine and oncology.
