Quality Systems Lead - GMP Manufacturing

New Horizon Medical Solutions LLC.; Simi Valley (CA); On-site; USD 95,000 - 160,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Paid time off

Professional development

Job summary

VictoGen seeks an experienced Quality Supervisor to build, implement, and maintain a compliant Quality Management System (QMS) for a growing pharmaceutical startup. You will drive quality across operations, manufacturing, and R&D with hands-on leadership in a fast-paced environment.

The role emphasizes FDA 21 CFR Parts 210/211, cGMP compliance, audits, deviations, CAPAs, and cross-functional collaboration to enable scalable quality processes and audit readiness.

Qualifications

• Education: bachelor’s degree in life sciences or related field.
• 5–7+ years of QA experience in pharmaceutical manufacturing.
• Knowledge of FDA 21 CFR Parts 210, 211 and cGMP regulations.
• Experience developing and implementing quality systems.
• Internal audit planning, execution, and reporting.

Responsibilities

• Develop, implement, and maintain the QMS in compliance with FDA requirements.
• Author, review, and approve SOPs, batch records, and controlled documents.
• Lead internal audits and respond to audit observations with CAPAs.
• Manage deviations, change controls, investigations, and document control.
• Collaborate with Operations, Manufacturing, and R&D.

Skills

Quality systems knowledge

Audits & inspections

Documentation & investigations

CAPA management

Cross-functional collaboration

Problem-solving

Regulatory compliance

Education

Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, or related field

Tools

Electronic QMS systems

Job description

VictoGen seeks an experienced Quality Supervisor to build, implement, and maintain a compliant Quality Management System (QMS) for a growing pharmaceutical startup. You will drive quality across operations, manufacturing, and R&D with hands-on leadership in a fast-paced environment.

The role emphasizes FDA 21 CFR Parts 210/211, cGMP compliance, audits, deviations, CAPAs, and cross-functional collaboration to enable scalable quality processes and audit readiness.