GMP Operations Lead - Cleanroom & Compliance

Victo Gen is committed to delivering high-quality products and services that meet or exceed customer expectations through a strong focus on operational excellence, continuous improvement, and regulatory compliance. Our success is driven by a culture of accountability, integrity, and employee commitment to quality at every level of the organization.

At Victo Gen, we value collaboration, precision, and purpose. Each team member plays a meaningful role in upholding our standards, supporting our customers, and contributing to a safe, compliant, and high-performing workplace.

Position Overview

We are a growing pharmaceutical CDMO seeking an Operations Supervisor to support and oversee daily GMP laboratory and cleanroom operations. This is a hands-on role for a working supervisor who thrives in a startup environment and is comfortable leading frontline operations while ensuring compliance with cGMP standards.

The Operations Supervisor will be responsible for coordinating daily production activities, supervising staff, and maintaining operational readiness of cleanroom environments while partnering closely with Quality and Operations leadership.

Key Responsibilities

Cleanroom & GMP Operations

• Supervise daily GMP cleanroom operations, including ISO-classified environments
• Ensure adherence to gowning procedures, aseptic techniques, and contamination control practices
• Monitor cleanroom behaviors, environmental conditions, and documentation accuracy
• Coordinate cleaning, sanitization, and environmental monitoring schedules
• Ensure proper material, personnel, and waste flow within controlled environments
• Support audit readiness activities including FDA inspections, client audits, and internal audits

Operations & Team Supervision

• Supervise and support laboratory and production staff (initially 3–10 employees)
• Provide hands-on training, coaching, and performance feedback to team members
• Execute SOPs, batch records, logbooks, and controlled documentation processes
• Partner with Quality on deviations, CAPAs, change controls, and investigations
• Support technology transfer and manufacturing activities for client programs
• Monitor equipment usage, coordinate calibration, and support preventive maintenance
• Identify opportunities for process improvements and support Lean initiatives
• Assist with onboarding and day-to-day workforce coordination

Minimum Qualifications

• Education: Bachelor’s degree in Operations, Engineering, Life Sciences, or related field (or equivalent experience)
• Experience:
• Minimum 5–7 years in pharmaceutical, biotech, or regulated manufacturing environment
• Minimum 2–3 years in a lead or supervisory role
• Hands-on experience working in GMP clean rooms or controlled environments
• Working knowledge of aseptic technique and contamination control
• Strong understanding of cGMP requirements (FDA, USP standards)
• Experience following and enforcing SOPs and documentation practices

Preferred Qualifications

• Experience in a pharmaceutical CDMO/CMO environment
• Exposure to FDA inspections or client audits
• Experience in startup or early-stage manufacturing environments
• Familiarity with Lean Manufacturing or continuous improvement methodologies
• Strong documentation, training, and cross-functional communication skills

Physical & Work Environment Requirements

• Ability to stand, walk, sit, bend, reach, and move throughout the facility as needed.
• Ability to lift and carry up to 25 pounds and occasionally up to 50 pounds with assistance, as appropriate.
• Ability to work in office, manufacturing, warehouse, and/or controlled environments.
• Ability to wear required personal protective equipment (PPE).
• Ability to safely work around manufacturing equipment and operational areas.
• Reasonable accommodations may be provided to enable qualified individuals with…