Description
The QA Compliance Lead Auditor is a senior-level role based in the US, with a preference for candidates near Durham, NC. This position is within Fortrea's Global Quality Assurance organisation, responsible for providing regulatory expertise, leading complex GCP audits and inspections, and driving global quality initiatives.
Key Responsibilities
- 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.
- 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.
- Facilitate and review audit and inspection responses, including assessment and challenge of responses, corrective actions, and CAPAs.
- Track audit and inspection commitments, CAPAs, supporting evidence, and follow-up activities through completion and closure.
- 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.
- Maintain current professional and technical knowledge through continuing education, regulatory guidance, relevant publications, and professional networks.
Minimum Qualifications
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
- Relevant and equivalent experience may be considered in lieu of formal education.
- Fluent in English, written and verbal.
Required Experience
- 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.
- Strong strategic communication skills with clients and internal stakeholders.
- Experience leading or contributing to quality and process improvement initiatives reducing inspection risks and strengthening inspection readiness.
Preferred Qualifications
- Postgraduate degree (MSc or equivalent) in a scientific or management-related discipline.
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.
Pay Range: USD $70,000-$125,000
Benefits: Comprehensive benefits including Medical, Dental, Vision, Life, STD/LTD, 401(K), Flexible time off (FTO).