Senior QA & External Audit Leader (Remote NC)

Lifelancer; United States; Remote; USD 93,000 - 207,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k) Matching

Paid Time Off

Job summary

Fortrea seeks a Senior Manager QA, External Audit, NC remote based to lead critical audit and inspection programs, strengthening quality systems and driving continuous improvement across clinical operations.

You will oversee client audits, readiness planning, and engagement with stakeholders to ensure regulatory readiness, collaborating with regional leaders and executives to uphold a strong culture of quality.

Qualifications

• 10+ years in GxP auditing or related clinical quality experience.
• 5+ years leading sponsor audits or regulatory inspections.
• Senior-level oversight of audit findings, CAPAs and closures.
• Experience leading cross-functional teams across multiple sites.
• Bachelor's in Life Sciences preferred or equivalent experience.

Responsibilities

• Oversee client audits, for-cause audits and inspection activities with staffing and planning.
• Provide strategic oversight for complex external audit activities and readiness planning.
• Partner with regional leaders to support a culture of quality.
• Ensure SOP implementation and regulatory interpretation across policies.
• Escalate issues to management and drive preventative actions.
• Lead process improvements using data, metrics and dashboards.
• Manage interactions with clients and regulators and represent Fortrea externally.

Skills

GxP auditing

Regulatory inspections

Audit leadership

Quality systems

Cross-functional leadership

Education

Bachelor's in Life Sciences

Job description

Fortrea seeks a Senior Manager QA, External Audit, NC remote based to lead critical audit and inspection programs, strengthening quality systems and driving continuous improvement across clinical operations.

You will oversee client audits, readiness planning, and engagement with stakeholders to ensure regulatory readiness, collaborating with regional leaders and executives to uphold a strong culture of quality.