Principal Quality Auditor - GCP

Principal Quality Auditor - GCP

Remote, United States

Position Summary: 

The Principal Quality Auditor is responsible for providing senior oversight and subject matter expertise to quality and compliance activities, supporting the Q&C Management team, Q&C team members, and the project teams during all stages of a clinical study.  

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

• Serve as a subject matter expert for clinical project teams 
• Uses ability and specialized skill to complete difficult tasks. Develops and implements concepts and/or techniques to achieve objectives 
• Understands Precision processes and functional SME organization to work through complex tasks independently to resolution 
• Support the Quality Management System including SOPs, training and CAPA  
• Attends project meetings, representing Quality. Reviews project plans and provides compliance guidance on complex issues independently.  
• 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  
• 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  
• Support Proposals and Bid Defense meetings as needed 
• Additional tasks as required  

Qualifications: 

Minimum Required: 

• 5 years of experience 
• Working knowledge of GCP/ICH guidelines and FDA regulations and standards  
• Audit experience conducting a variety of audit types, including internal systems, vendors, TMF and investigator site audits. 

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  

• Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient.  
• Demonstrates mastery knowledge of ICH-GCP, relevant Precision SOPs, and compliance guidance, as well as the ability to implement  
• Proficient in Microsoft Word, Excel, and PowerPoint  
• Ability to support senior leadership in Q&C Management tasks and projects, offering solutions and processes for increased efficiencies within the department.  
• Ability to develop, coach and mentor Q&C staff.  
• Demonstrates a solid working knowledge of e-Clinical systems/platforms.  
• Demonstrates strong interpersonal skills.  
• Ability to lead and inspire excellence within a team  
• Results oriented, accountable, motivated and flexible  
• Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment.  
• Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, possess good. interpersonal skills and maintain positive interactions with internal and external stakeholders.  
• Demonstrates values and a work ethic consistent with Precision Values and Company Principles.  
• Excellent verbal and written communications skills