GxP Quality Auditor / Sr Quality Lead

GxP Quality Auditor / Senior Quality Lead

Location: Greenville, NC
Employment Type: Full-Time, On-Site
Salary Range: $87,780 - $145,307/year

Company Overview

A leading life sciences organization is seeking a GxP Quality Auditor / Senior Quality Lead to support compliance and quality governance across multiple manufacturing lines. This company partners with global pharmaceutical and biotech firms to deliver solutions that ensure regulatory excellence and operational integrity.

Position Summary

The GxP Quality Auditor / Senior Quality Lead will play a critical role in maintaining compliance with global regulatory standards and driving quality initiatives. This position requires expertise in pharmaceutical compliance, bracketing strategies, and regulatory interpretation in a GMP-regulated environment.

Key Responsibilities

• Coordinate between site and global teams to align SOPs and bracketing strategy
• Provide regulatory and technical interpretation to ensure compliance with FDA, EMA, and HMRA requirements
• Develop and defend bracketing justification for multiple manufacturing lines and isolators
• Facilitate governance meetings, escalate risks, and report status to leadership
• Review and approve protocol templates, summaries, and reports for finalization

Qualifications

• Bachelor's degree in a scientific or industry-related field
• Minimum 7+ years of experience in pharmaceutical manufacturing or compliance
• Proven experience developing bracketing and matrixing strategies
• Strong knowledge of FDA, EMA, and HMRA regulations
• Familiarity with cGMP and facility/equipment validation requirements
• Excellent technical writing and communication skills
• Ability to work full-time on-site in Greenville, NC

Why Join This Team?

• Competitive compensation and performance-based incentives
• Comprehensive benefits package including medical, dental, vision, and retirement plans
• Paid time off, holidays, and professional development opportunities
• Collaborative culture with strong career growth potential