About the Role
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
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
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