Senior GxP Auditor & Quality Assurance Leader

Parexel; India (PA); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Parexel is seeking an Auditor (Quality Assurance Auditor) to lead and execute comprehensive GxP audits across all phases of clinical research, ensuring regulatory compliance and high-quality standards. You will evaluate quality systems, identify improvements, and support trial integrity in a fast-paced, growth-oriented setting.

You will collaborate with cross-functional teams, deliver actionable audit reports, and mentor junior staff while maintaining client relationships and meeting project

Qualifications

• Bachelor's degree in biological science, technology, pharmacy, or related field.
• 2+ years in quality assurance and auditing with GxP experience.
• 5+ years in regulatory affairs or clinical research related areas.

Responsibilities

• Plan, lead, and execute GxP audits across all clinical phases.
• Deliver high-quality audit reports within timelines and budgets.
• Manage audit findings and support corrective actions with stakeholders.
• Coordinate internal audit programs globally and regionally.

Skills

GxP audits

Regulatory compliance

Audit reporting

Cross-functional collaboration

Project management

Quality assurance

Education

Bachelor's degree in biological science or related field

Master's degree (preferred)

Tools

Microsoft Office

Audit tools (GxP)

Job description

Parexel is seeking an Auditor (Quality Assurance Auditor) to lead and execute comprehensive GxP audits across all phases of clinical research, ensuring regulatory compliance and high-quality standards. You will evaluate quality systems, identify improvements, and support trial integrity in a fast-paced, growth-oriented setting.

You will collaborate with cross-functional teams, deliver actionable audit reports, and mentor junior staff while maintaining client relationships and meeting project