GMP Operations Lead - Cleanroom & Compliance

New Horizon Medical Solutions LLC.; Simi Valley (CA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical, dental & vision

Paid time off & holidays

Professional development

Job summary

VictoGen seeks an Operations Supervisor to lead daily GMP laboratory and cleanroom operations in a startup‑like, high‑compliance environment. The role requires coordinating production activities, supervising staff (initially 3–10), and ensuring alignment with Quality and Operations leadership to maintain readiness and regulatory compliance.

Responsibilities include supervising daily GMP cleanroom activities, attending to SOPs and batch records, and supporting audits (FDA, client, internal).

Qualifications

• Bachelor’s degree and 5–7 years in pharmaceutical/regulated manufacturing.
• 2–3 years in a lead or supervisory role.
• Hands-on experience in GMP cleanrooms or controlled environments.
• Strong understanding of cGMP (FDA, USP) requirements.
• Experience following and enforcing SOPs and documentation practices.

Responsibilities

• Supervise daily GMP cleanroom operations and ISO-classified environments.
• Ensure gowning, aseptic technique, and contamination control adherence.
• Monitor environmental conditions and documentation accuracy; manage schedules for cleaning and environmental monitoring.
• Supervise 3–10 staff; provide hands-on training and performance feedback.
• Coordinate with Quality on deviations, CAPAs, change controls, and investigations.
• Support technology transfer and manufacturing activities for client programs.

Skills

Team supervision

GMP knowledge

Aseptic technique

Documentation practices

Lean/Continuous Improvement

Education

Bachelor’s degree in Operations, Engineering, Life Sciences, or related field

Job description

VictoGen seeks an Operations Supervisor to lead daily GMP laboratory and cleanroom operations in a startup‑like, high‑compliance environment. The role requires coordinating production activities, supervising staff (initially 3–10), and ensuring alignment with Quality and Operations leadership to maintain readiness and regulatory compliance.

Responsibilities include supervising daily GMP cleanroom activities, attending to SOPs and batch records, and supporting audits (FDA, client, internal).