Senior Manager QA, Remote

Senior Manager QA, Remote based in North Carolina 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.

Location:

Preference will be given to candidates located in or near the Raleigh-Durham, North Carolina area.

• You will 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.
• You will 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.
• You will partner with regional and functional leaders on key initiatives, providing Quality SME input and supporting a strong culture of quality.
• You will 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.
• You will communicate escalation issues to management and lead appropriate solutions, including preventative actions, risk mitigation and regular leadership updates.
• You will lead functional process improvement initiatives, using data analysis, metrics and dashboards to drive the efficiency and effectiveness of Regulatory Compliance and Quality Assurance processes.
• You will lead and effectively manage critical interactions with clients and regulatory agencies and represent Fortrea during external meetings, conferences and seminars as an industry SME.
• You will recruit, train, coach and develop leaders and mentor RC and QA resources, including performance and workload management across multiple sites or geographic locations.
• And all other duties as assigned.

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 preferred. 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.

A bachelor’s degree in Life Sciences is preferred, or equivalent Life Science experience. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. 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.

Fortrea is unable to provide employment sponsorship for this position, now or in the future. Candidates must be authorized to work in the United States without sponsorship.

• 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.