Senior Quality Auditor

Position Summary: 

The Senior Quality Auditor supports the audit program and clinical projects to ensure compliance with regulations and Precision procedures.  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  
• Additional tasks as required  

Qualifications: 

Minimum Required:  

• 4 years industry experience  
• Clinical research experience in non-QA role considered (e.g., clinical research associate experience)  
• Working knowledge of GCP/ICH guidelines and FDA regulations and standards  

Other Required: 

• 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, Pharmaceutical and/or Medical device experience  
• QA certification preferred (e.g., CQA, SQA, etc.)  
• Experience with electronic clinical trial systems (e.g., EDC, CTMS, IxRS, ePRO, etc.)  

Skills: 

• Excellent interpersonal and problem-solving skills, effective verbal and written communication, computer skills 

Competencies  

• 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