Associate Manager, QA Auditor - Remote

Overview

The Associate Manager QA Auditor applies expertise in Good Pharmacovigilance Practice (GxP) and international regulations to the auditing process to independently address a variety of GVP compliance issues associated with drug development and post-marketing authorization.

In Short

• Conducts audits in support of GxP compliance.
• Schedules and prepares audits as directed.
• Coordinates audit team activities.
• Reports findings to management with recommendations.
• Ensures compliance with FDA and EU regulations.
• Represents QA on compliance projects.
• Evaluates quality systems for compliance.
• Escalates compliance issues appropriately.
• Requires a Bachelor’s degree and 4+ years of experience.
• Excellent communication and leadership skills are essential.

Requirements

• Bachelor’s degree.
• 4+ years of relevant industry experience.
• In-depth knowledge of FDA and EU regulations.
• Experience with regulatory inspections.
• Strong leadership skills.
• Ability to work with senior leaders.
• Excellent communication skills.
• Experience in conducting audits.
• Knowledge of GxP compliance.
• Ability to interpret policies and standards.

Benefits

• Comprehensive health and wellness programs.
• Access to fitness centers.
• Equity awards and annual bonuses.
• Paid time off for eligible employees.
• Inclusive and diverse workplace culture.
• Equal opportunity employer.
• Reasonable accommodations for disabilities.
• Background checks conducted in accordance with local law.
• Recognized as a Great Place to Work.
• Innovative company culture.