Senior QA & External Audit Lead - Remote NC

Fortrea; Durham (NC); Remoto; USD 93.000 - 207.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical

Dental

Vision

Life

STD/LTD

401(K)

Paid time off (PTO) or Flexible time

Company bonus

Descrizione del lavoro

Fortrea is seeking a Senior Manager QA, External Audit, Remote based in North Carolina to lead client audits, for-cause audits, and regulatory inspections. You will shape readiness programs, guide response strategies, and drive a culture of quality across clinical operations in collaboration with cross-functional partners.

Preference will be given to candidates in the Raleigh-Durham area. The role involves travel to sites, partnering with regulatory agencies, mentoring leaders, implementing

Competenze

• 10+ years in GxP auditing, QA, regulatory inspection support, or external audit hosting.
• Experience leading sponsor audits, regulatory inspections, or for-cause audits.
• Experience providing senior-level oversight of audit findings and CAPAs.
• Experience leading cross-functional teams and audit readiness strategy.
• Previous line management experience across multiple sites.

Mansioni

• Oversee and lead execution of client audits, for-cause audits, and inspection activities.
• Provide strategic oversight for complex external audit and inspection activities.
• Partner with regional and functional leaders to support quality culture.
• Ensure consistent SOP use and interpretation of quality regulations.
• Communicate escalations and lead preventative actions.
• Lead process improvement initiatives using data, metrics, dashboards.
• Manage interactions with clients and regulatory agencies.
• Recruit, train, coach, and develop leaders across sites.
• Perform other duties as assigned.

Conoscenze

GxP auditing

Quality assurance

Regulatory inspection support

External audit hosting

Clinical research quality

Audit coordination

Cross-functional leadership

Senior-level oversight

Line management

Formazione

Bachelor's degree in Life Sciences

Descrizione del lavoro

Fortrea is seeking a Senior Manager QA, External Audit, Remote based in North Carolina to lead client audits, for-cause audits, and regulatory inspections. You will shape readiness programs, guide response strategies, and drive a culture of quality across clinical operations in collaboration with cross-functional partners.

Preference will be given to candidates in the Raleigh-Durham area. The role involves travel to sites, partnering with regulatory agencies, mentoring leaders, implementing