Senior GCP Process Auditor

About the Role

Precision Medicine Group operates in a dynamic environment where innovation and precision are key. The company's unique integrated offering combines novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and a passion for rare diseases and oncology. As the company continues to grow and expand its services, the need for a skilled Senior GCP Process Auditor who can navigate the complexities of global regulations and standards has become paramount.

The day-to-day responsibilities of this role will include supporting the Quality Management System, developing and administering training for employees and consultants, hosting client and sponsor audits, and coordinating internal audits of quality systems. The ideal candidate will be able to work independently and as part of a team, providing QA consultation and support to project teams and managing reported quality issues. This role requires a high level of organizational skill, attention to detail, and the ability to prioritize tasks effectively.

What You Will Do

• 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 on GCP, ICH, and FDA regulations and standards.
• Host client/sponsor audits and support regulatory inspections to ensure compliance with regulatory requirements.
• Coordinate and conduct assessments of potential and contracted vendors, including vendor audits as warranted.
• Coordinate and conduct internal audits of quality systems to identify areas for improvement.
• Coordinate and conduct investigator site audits to ensure compliance with GCP and regulatory requirements.
• Coordinate and conduct trial master file audits to ensure that all necessary documents are accurate and complete.
• Participate in computer systems validation projects and systems change control process to ensure that all systems are compliant with regulatory requirements.
• 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 to ensure that all quality-related data is accurate and up-to-date.

What We Are Looking For

• 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; a combination of qualifications and equivalent relevant experience may be accepted as an alternative.
• Availability to travel up to 25% domestically and/or internationally for audits and other business needs.
• Strong understanding of quality management systems and the ability to apply this knowledge in a practical setting.
• Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.
• Strong organizational and time management skills, with the ability to prioritize tasks and meet deadlines.
• Experience with electronic clinical trial systems (e.g., EDC, CTMS, IxRS, ePRO, etc.) is preferred.

Nice to Have

• CRO experience, particularly in a similar role or in a quality assurance capacity.
• QA certification (e.g., CQA, SQA, etc.) is highly desirable.
• Experience with audit management software and tools.
• Knowledge of other regulatory requirements and standards, such as those applicable in the EU and other regions.
• Experience in managing and coordinating audits in a global setting.

Benefits and Perks

• Competitive salary and benefits package.
• Opportunity to work with a global leader in precision medicine.
• Collaborative and dynamic work environment.
• Professional development opportunities, including training and education support.
• Flexible working arrangements, including remote work options.
• Access to cutting-edge technologies and systems.
• Recognition and reward for outstanding performance.
• Comprehensive health insurance and wellness programs.
• Generous paid time off and holidays.

• Develop a strong understanding of GCP, ICH, and FDA regulations to stand out in your application and during interviews.
• Highlight your experience with audit management software and tools in your resume and cover letter to demonstrate your technical skills.
• Prepare examples of your experience in managing quality issues and implementing corrective actions, as these will be crucial in demonstrating your capabilities to potential employers.
• Showcase your ability to work independently and as part of a team, as this role requires both skill sets.
• Research the company's values and mission to understand how your skills and experience align with their goals, and be prepared to discuss this during interviews.
• Consider obtaining QA certification if you haven't already, as this can significantly enhance your application and demonstrate your commitment to quality assurance.