# Senior Manager QA **Company**: Fortrea **Location**: Durham **Work arrangement**: remote **Experience**: senior **Job type**: full-time **Salary**: USD $93,300-206,800 / annually **Category**: Operations **Industry**: Healthcare **Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Durham/Senior-Manager-QA--External-Audit_266385?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_dd064958-556 ## Description Join Fortrea as a Senior Manager QA, External Audit, NC remote based, and make an impact on the quality of clinical research by leading critical audit and inspection programs. In this highly collaborative role, you'll influence a culture of quality, strengthen quality systems, and drive continuous improvement across clinical operations. **Key Responsibilities:** - Oversee and lead the execution of client audits, for-cause audits, and inspection activities, ensuring appropriate staffing, planning, conduct, and follow-through to meet client and regulatory inspector expectations. - Provide strategic oversight for complex or high-risk external audit and inspection activities, including readiness planning, stakeholder engagement, response strategy, escalation management, and leadership communication. - Partner with regional and functional leaders on key initiatives, providing Quality SME input and supporting a strong culture of quality. - Ensure consistent functional implementation, use, and review of SOPs, and interpret applicable quality regulations and standards to ensure appropriate policies and procedures are revised or created. - Communicate escalation issues to management and lead appropriate solutions, including preventative actions, risk mitigation, and regular leadership updates. - Lead functional process improvement initiatives, using data analysis, metrics, and dashboards to drive the efficiency and effectiveness of Regulatory Compliance and Quality Assurance processes. - Lead and effectively manage critical interactions with clients and regulatory agencies, and represent Fortrea during external meetings, conferences, and seminars as an industry SME. - Recruit, train, coach, and develop leaders, and mentor RC and QA resources, including performance and workload management across multiple sites or geographic locations. **Required Qualifications:** - 10+ years of specialized GxP auditing, quality assurance, regulatory inspection support, external audit hosting, or related clinical research quality experience. - At least 5 years of experience leading, managing, hosting, or coordinating sponsor audits, regulatory inspections, or for-cause audits. - Demonstrated experience providing senior-level oversight of audit findings, response strategies, root cause rationale, corrective actions, CAPAs, evidence, escalation, and closure activities. - Experience leading cross-functional teams, managing complex stakeholder expectations, presenting leadership, and driving audit or inspection readiness strategy. - Previous line management experience, including performance management, coaching, and workload management, with the ability to lead and support teams across multiple sites or geographic locations. **Preferred Qualifications:** - A bachelor's degree in Life Sciences is preferred, or equivalent Life Science experience. - Experience and regulatory expertise in industry quality systems and standards, including the ability to interpret applicable regulations and use data to lead process improvement initiatives. **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 stationery 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 $93,300-206,800 / annually **Benefits:** - Comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable. ## Skills ### Required - GxP auditing - quality assurance - regulatory inspection support - external audit hosting - clinical research quality ### Nice to have - Life Sciences degree - regulatory expertise in industry quality systems and standards --- Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Durham/Senior-Manager-QA--External-Audit_266385?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)