Principal GCP Quality Assurance Auditor

Summary

Join Precision for Medicine as a Principal Quality Assurance Auditor and provide senior oversight and subject matter expertise to quality and compliance activities. You will serve as a subject matter expert for clinical project teams, support the Quality Management System, conduct various audits (vendor, internal, investigator site, TMF), and participate in computer systems validation projects. This role requires a minimum of 5 years of experience, a Bachelor’s degree in a related field, and working knowledge of GCP/ICH guidelines and FDA regulations. Preferred qualifications include CRO experience and QA certification. The position offers a competitive salary, annual bonus, health insurance, retirement savings benefits, life and disability insurance, parental leave, and paid time off.

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

Responsibilities

• 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

Preferred Qualifications

• 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.)

Benefits

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