Principal Quality Auditor - GCP

Precision Medicine Group

124d • $96,500 - $144,700

About The Position

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.

Requirements

• 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
• 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

Nice To Haves

• 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.)

Responsibilities

• Serve as a subject matter expert for clinical project teams
• Develop and implement concepts and/or techniques to achieve objectives
• Support the Quality Management System including SOPs, training and CAPA
• Attend project meetings, representing Quality
• Review project plans and provide compliance guidance on complex issues
• Process and maintain documentation for controlled documents
• 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
• 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
• Maintain Q&C trackers, databases, metrics, and files
• Follow applicable regulations and standards
• Support Proposals and Bid Defense meetings as needed

Benefits

• Discretionary annual bonus
• Health insurance
• Retirement savings benefits
• Life insurance
• Disability benefits
• Parental leave
• Paid time off for sick leave and vacation

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees