Quality System Manager

Position Overview

The Quality Systems Manager will oversee and strengthen quality systems to ensure regulatory compliance and continuous improvement across pharmaceutical manufacturing operations.

Key Responsibilities

• Manage core quality systems including Deviations, CAPA, Change Control, Training, and Document Control
• Ensure ongoing compliance with cGMP and FDA regulations (21 CFR Parts 210 and 211)
• Lead investigations, root cause analysis, and CAPA effectiveness reviews
• Support regulatory inspections, customer audits, and internal audits
• Drive continuous improvement initiatives within the quality management system

Qualifications & Experience

• 3–7 years of experience in pharmaceutical quality systems within manufacturing or CDMO environments
• Strong working knowledge of FDA regulations and cGMP standards
• Experience with electronic Quality Management Systems (eQMS)
• Strong stakeholder management, problem-solving, and leadership skills