Remote GxP Audit Lead - Senior Technology Auditor

Parexel; United States; Remote; USD 90,000 - 140,000; Full time

Job summary

Parexel is seeking a QA Auditor to independently lead GxP audits across all phases of clinical research, including GMP, GLP, and PV areas. The role requires planning, execution, timely reporting, and collaboration with Operations and Quality to ensure compliance and high-quality audit outcomes.

You will travel internationally up to 60%, engage with client representatives and internal stakeholders, and develop strategic audit plans.

Qualifications

• 4+ years auditing experience in GxP environments.
• Experience across GMP, GLP, GCLP audits.
• Ability to plan, execute and report audits on time.
• Familiarity with CAPA processes.
• Strong communication and mentoring abilities.

Responsibilities

• Lead and coordinate GxP audits across phases.
• Develop strategic audit plans and client relations.
• Review audit findings and CAPA escalations.
• Maintain QA records and tools.
• Provide regulatory consultancy and training.

Skills

GxP auditing

Regulatory compliance

Quality systems

Audit reporting

Project coordination

Travel readiness

Education

Bachelor's degree in life sciences

QA/GLP/GCP certifications

Job description

Parexel is seeking a QA Auditor to independently lead GxP audits across all phases of clinical research, including GMP, GLP, and PV areas. The role requires planning, execution, timely reporting, and collaboration with Operations and Quality to ensure compliance and high-quality audit outcomes.

You will travel internationally up to 60%, engage with client representatives and internal stakeholders, and develop strategic audit plans.