Senior Manager QA, Remote based in North Carolina

Fortrea•Durham, CA

1d•$93,300 - $206,800•Remote

About The Position

Fortrea is seeking a Senior Manager QA, External Audit to lead critical audit and inspection programs and support quality in clinical research. This collaborative role influences a culture of quality, strengthens quality systems, and drives continuous improvement across clinical operations. The role is remote and based in North Carolina, with preference for candidates located in or near Raleigh-Durham. The Senior Manager provides strategic oversight for client audits, for-cause audits, and regulatory inspections, including planning, staffing, readiness, stakeholder engagement, response strategy, escalation management, and follow-through. The role partners with regional and functional leaders, interprets applicable quality regulations and standards, supports consistent implementation and review of SOPs, and leads process improvement using data, metrics, and dashboards. The position also manages client and agency interactions, represents Fortrea externally as an industry subject-matter expert, and recruits, coaches, and develops leaders and quality resources across multiple sites or geographic locations. Work is performed in an office environment with exposure to electrical office equipment. Occasional drives to site locations and occasional domestic and international travel are expected. Varied hours may be required. Candidates must be authorized to work in the United States without employment sponsorship, now or in the future.

Requirements

10 or more years of specialized GxP auditing, quality assurance, regulatory inspection support, external audit hosting, or related clinical research quality experience.
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 to 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.
Must be authorized to work in the United States without employment sponsorship, now or in the future.

Nice To Haves

At least 5 years of experience leading, managing, hosting, or coordinating sponsor audits, regulatory inspections, or for-cause audits.
Bachelor’s degree in Life Sciences or equivalent Life Science experience; relevant and equivalent experience may be considered in lieu of educational requirements.
Experience and regulatory expertise in industry quality systems and standards, including interpreting applicable regulations and using data to lead process-improvement initiatives.

Responsibilities

Oversee and lead client audits, for-cause audits, and inspection activities, including staffing, planning, conduct, and follow-through.
Provide strategic oversight for complex or high-risk external audits and inspections, including readiness planning, stakeholder engagement, response strategy, escalation management, and leadership communication.
Partner with regional and functional leaders on key initiatives, provide Quality subject-matter expertise, and support a strong culture of quality.
Ensure consistent functional implementation, use, and review of SOPs; interpret applicable quality regulations and standards and ensure appropriate policies and procedures are revised or created.
Communicate escalation issues to management and lead solutions, including preventative actions, risk mitigation, and regular leadership updates.
Lead functional process-improvement initiatives, using data analysis, metrics, and dashboards to improve Regulatory Compliance and Quality Assurance processes.
Lead interactions with clients and regulatory agencies and represent Fortrea at external meetings, conferences, and seminars as an industry subject-matter expert.
Recruit, train, coach, and develop leaders; mentor Regulatory Compliance and Quality Assurance resources; and manage performance and workloads across multiple sites or geographic locations.
Perform other duties as assigned.