Job Description
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 Qua...