Global GxP QA Auditor Lead

Parexel; United States; Remote; USD 90,000 - 150,000; Full time

Job summary

Parexel is seeking a Quality Assurance Auditor to lead and report on GxP audits across Clinical Research, ensuring compliance with GMP/GLP standards and regulatory guidelines. You will drive audit quality, mentor peers, and support client programs globally.

The role emphasizes cross-functional collaboration, ongoing process improvements, and the ability to travel internationally up to 60% to support audits and client engagements.

Qualifications

• Minimum 4 years of quality assurance and auditing experience.
• Deep knowledge of GxP requirements and regulatory guidelines (GMP/GLP).
• Experience leading audits and preparing audit reports.
• Ability to mentor auditors and coordinate cross-functional teams.

Responsibilities

• Lead, plan, and report GxP audits across Clinical Research, including GMP/GLP and PV audits.
• Review audit findings and ensure timely, quality CAPA responses.
• Coordinate internal global audit programs and develop tools/templates.
• Maintain client relationships and ensure audits meet Parexel requirements.
• Support sponsor audits and regulatory inspections; liaise with regulators as needed.

Skills

Audit leadership

GxP auditing

Regulatory knowledge

Client liaison

Team mentoring

Travel readiness

Education

Bachelor's degree life sciences

Master’s degree preferred

Tools

Microsoft Office

Job description

Parexel is seeking a Quality Assurance Auditor to lead and report on GxP audits across Clinical Research, ensuring compliance with GMP/GLP standards and regulatory guidelines. You will drive audit quality, mentor peers, and support client programs globally.

The role emphasizes cross-functional collaboration, ongoing process improvements, and the ability to travel internationally up to 60% to support audits and client engagements.