Principal Quality Auditor - GCP

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  

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Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range esti