Senior QA & External Audit Leader (Remote NC)

Fortrea; North Carolina; Remoto; USD 93.000 - 207.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, Dental, Vision

Life Insurance

STD/LTD

401(k)

PTO/FTO

Company bonus where applicable

Descrizione del lavoro

Fortrea seeks a Senior Manager QA, External Audit, NC remote based to lead audit and inspection programs across clinical operations. The role combines strategic oversight with hands-on leadership to strengthen quality systems and drive continuous improvement.

You will oversee client audits, prepare responses, mentor QA teams, and partner with regional leaders to implement SOPs and regulatory compliance. Preference for candidates in the Raleigh-Durham area; some travel domestically and

Competenze

• 10+ years of specialized GxP auditing and QA in clinical research.
• 5+ years leading sponsor audits or regulatory inspections.
• Senior-level oversight of audit findings, CAPAs, and escalation.
• Experience guiding cross-functional teams across multiple sites.

Mansioni

• Oversee and lead client audits, for-cause audits and inspections.
• Provide strategic oversight for external audit activities, including readiness planning.
• Partner with regional leaders on initiatives to promote quality culture.
• Ensure SOP implementation and regulatory compliance across policies.
• Communicate escalations and drive preventative actions and risk mitigation.
• Lead process improvements using data, metrics, and dashboards in QA/Regulatory.
• Manage interactions with clients and regulatory agencies and represent Fortrea.
• Recruit, train, coach and develop leaders across sites.
• And all other duties as assigned.

Conoscenze

GxP auditing

Quality assurance

Regulatory inspections

External audit hosting

Cross-functional leadership

Formazione

Bachelor's degree in Life Sciences

Descrizione del lavoro

Fortrea seeks a Senior Manager QA, External Audit, NC remote based to lead audit and inspection programs across clinical operations. The role combines strategic oversight with hands-on leadership to strengthen quality systems and drive continuous improvement.

You will oversee client audits, prepare responses, mentor QA teams, and partner with regional leaders to implement SOPs and regulatory compliance. Preference for candidates in the Raleigh-Durham area; some travel domestically and