Senior GCP Quality & Compliance Auditor - Remote

Overview

The Senior Quality & Compliance Auditor ensures adherence to company policies and global regulatory requirements in clinical research, playing a critical role in quality assurance and compliance.

In Short

• Lead and execute quality and compliance audits for clinical research.
• Develop strategic, risk-based audit plans.
• Provide consultation on GxP requirements.
• Coordinate audits with project management teams.
• Facilitate audits with external auditors and regulatory authorities.
• Analyze audit findings and prepare detailed reports.
• Oversee corrective action/preventative action (CAPA) plans.
• Conduct trend analysis on audit findings.
• Develop and lead auditor training programs.
• Stay updated on evolving regulations in clinical research.

Requirements

• Honor's Bachelor degree required.
• 7-9 years of experience in quality auditing in CRO or related fields.
• Understanding of compliance and risk management in clinical research.
• Previous team leadership experience.
• Certified Auditor (ASQ, ISO, or equivalent) preferred.
• Expertise in ICH GCP and related regulations.
• Strong technical knowledge in global regulations and industry standards.
• Excellent verbal and written communication skills.
• Strong analytical and problem-solving skills.
• Ability to manage workload independently and adapt to change.

Benefits

• Competitive salary and benefits package.
• Opportunities for professional development and training.
• Collaborative work environment.
• Engagement in impactful clinical research activities.
• Support for maintaining work-life balance.