Senior Auditor - Remote

Overview

The Senior Auditor is a critical role responsible for planning, leading, and executing complex internal and external GxP audits, ensuring high standards of product quality, safety, and regulatory compliance.

In Short

• Conduct vendor, investigator site, and internal audits according to GxP requirements.
• Prepare detailed audit reports and facilitate responses to audit observations.
• Support vendor management by performing audits of vendors.
• Manage the audit process through the quality management system.
• Lead initiatives to improve the Quality Management System (QMS).
• Provide guidance on GxP requirements to personnel.
• Assist during inspections and develop responses to agency observations.
• Provide audit metrics to Executive Management.
• Maintain knowledge of regulatory requirements (FDA, EU).
• Other duties as assigned.

Requirements

• Bachelor’s degree in health or life sciences; or relevant experience.
• 10+ years of experience in auditing and quality management systems.
• Professional certifications like ASQ Certified Quality Auditor preferred.
• Excellent communication skills with ability to influence at all levels.
• Strong interpersonal skills for cross-functional interaction.
• Attention to detail and ability to manage multiple processes.
• Analytical skills to evaluate complex compliance issues.
• Advanced knowledge in MS Office including Word, Excel, PowerPoint.
• Experience with Veeva Quality Vault software required.
• Ability to work independently or in a team as required.

Benefits

• Annual performance incentive bonus.
• New hire equity package.
• Medical, dental, vision insurance.
• 401(k) match.
• PTO and paid holidays.