Senior Quality Auditor

Job Description

Precision Medicine Group is seeking a Senior Quality Auditor to support the audit program and clinical projects, ensuring compliance with regulations and Precision procedures. The Senior Quality Auditor will provide oversight and subject matter expertise to quality and compliance activities, supporting project teams during all stages of a clinical study. Role involves:

• Supporting the Quality Management System including SOPs, training and CAPA.
• Processing and maintaining documentation for controlled documents.
• Developing and administering training for employees and/or consultants.
• Hosting client/sponsor audits and supporting regulatory inspections.
• Coordinating and conducting assessments of potential and contracted vendors, including vendor audits as warranted.
• Coordinating and conducting internal audits of quality systems.
• Coordinating and conducting investigator site audits.
• Coordinating and conducting trial master file audits.
• Participating on computer systems validation projects and systems change control process.
• Providing QA consultation and support to assigned project teams internally and externally.
• Supporting and managing reported quality issues and any associated corrective and preventive actions.
• Monitoring quality systems to provide feedback on compliance risks to QA management and identify opportunities for improvement.
• Maintaining Q&C trackers, databases, metrics, and files.
• Following applicable regulations and standards.

Requirements:

• 4 years industry experience.
• Clinical research experience in non-QA role considered.
• Working knowledge of GCP/ICH guidelines and FDA regulations and standards.
• Bachelor’s degree in a science, healthcare, or related field of study.
• Availability to travel up to 25% domestically and/or internationally.
• Excellent interpersonal and problem-solving skills, effective verbal and written communication, computer skills.
• Strong knowledge of GCP/ICH guidelines and FDA regulations and industry standards.
• Intermediate proficiency in Microsoft Word, Excel, and PowerPoint.
• Must possess a customer service demeanor; demonstrate collaboration and flexibility, teamwork, and a keen attention to detail.
• Ability to work independently and in a team environment.
• Ability to work with cross functional groups and management under challenging situations.
• Ability to prioritize work and handle multiple and/or competing assignments.
• Results oriented, accountable, motivated and flexible.
• Demonstrates values and a work ethic consistent with Precision Values and Company Principles.
• Excellent verbal and written communications skills.
• Fluent in English language.

Role offers:

• Opportunity to work with a leading clinical research organization.
• Chance to contribute to quality and compliance activities.
• Support for professional development and training.