QA Compliance Lead Auditor (GCP) North Carolina area  Remote Based

• →Conduct and lead risk-based, end-to-end GCP audits, including process, service provider/vendor, clinical investigator site, study, and for-cause audits.
• →Provide GCP subject matter expertise and regulatory guidance to internal stakeholders, project teams, and clients, including client- and regulatory authority-facing support as appropriate.
• →Coordinate and host sponsor qualification and routine audits, regulatory inspections, for-cause audits, and other external audit activities.
• →Serve as a primary QA point of contact throughout the audit and inspection lifecycle, supporting readiness, request management, document and system access, SME and interview coordination, and issue escalation.
• →Facilitate and review audit and inspection responses, including assessment and challenge of responses, corrective actions, and CAPAs to ensure they adequately address reported observations.
• →Track audit and inspection commitments, CAPAs, supporting evidence, and follow-up activities through completion and closure, escalating significant or overdue items as appropriate.
• →Maintain a strong working knowledge of the Quality Management System (QMS) and support the timely progression, tracking, escalation, and closure of quality issues and associated CAPAs.
• →Support QA-to-QA relationships with key strategic clients.
• →Lead or support quality metrics, trend reporting, Quality Reviews, and global Quality initiatives focused on compliance, consistency, and efficiency.
• →Contribute to the development and interpretation of global QA policies and ensure activities are conducted in accordance with applicable regulatory requirements and controlled documents.
• →Deliver audit-related training and provide cross-training, mentoring, and coaching to auditors, audit hosts, and audit support staff, as appropriate.
• →Maintain current professional and technical knowledge through continuing education, regulatory guidance, relevant publications, and professional networks.
• →Perform other related duties as assigned.

·       Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.

• Postgraduate degree (MSc or equivalent) in a scientific or management‑related discipline.

Applicants must be legally entitled to work in US without the need for employer-sponsored work permits. This position is not eligible for sponsorship.

Work Environment:

·       Work is performed in an office environment with exposure to electrical office equipment.

·       Occasional drives to site locations with occasional travel both domestic and international.

Physical Requirements:

·       Frequently stationary for 6-8 hours per day.

·       Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.

·       Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.

·       Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

·       Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

·       Regular and consistent attendance.

·       Varied hours may be required.

• Minimum 8 years of experience in a regulated environment, including GxP roles.
• Demonstrated regulatory expertise with detailed knowledge of GCP and applicable global regulations.
• Experienced Lead GCP Auditor with strong critical thinking and risk-based assessment skills.
• Strong understanding of Quality Management Systems (QMS), quality issue management, and CAPA processes, including tracking issues and actions through timely resolution and closure.
• ·Strong strategic communication skills with clients and internal stakeholders.
• Experience leading or contributing to quality and process improvement initiatives reducing inspection risks and strengthen inspection readiness.

Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), Flexible time off (FTO).

Application Deadline: 11/08/26

Learn more about our EEO & Accommodations request here.