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New Horizon Medical Solutions LLC.

Quality Supervisor – Pharmaceutical Manufacturing (Startup Environment)

simi valley, CA

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Job description

VictoGen 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 VictoGen, 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 startup seeking an experienced Quality Supervisor to build, implement, and maintain a compliant Quality Management System (QMS). This role is ideal for a hands-on quality professional with a varied background who thrives in early-stage environments and is comfortable owning quality processes end-to-end.

The Quality Supervisor will play a critical role in ensuring compliance with FDA regulations and cGMP requirements while supporting operational growth, manufacturing activities, and audit readiness.

Key Responsibilities

Quality Systems & Compliance

Develop, implement, and maintain the company’s Quality Management System (QMS) in compliance with FDA 21 CFR Parts 210 and 211

Author, review, and approve SOPs, batch records, forms, and controlled documents

Ensure compliance with cGMP regulations across manufacturing, laboratory, and support operations

Serve as the primary quality point of contact for internal teams

Audits & Inspections

Plan and conduct internal audits and self-inspections

Support and host FDA inspections, client audits, and third-party audits

Lead responses to audit observations, including CAPAs and corrective action tracking

Quality Operations

Manage deviations, nonconformances, change controls, and investigations

Oversee document control, training programs, and quality metrics

Review and approve batch records and quality-related documentation

Support supplier qualification and quality agreements

Partner cross-functionally with Operations, Manufacturing, and R&D teams

Startup & Growth Support

Build scalable quality processes suitable for a growing organization

Provide quality guidance during process development, scale-up, and tech transfer

Train and mentor staff on quality principles, GMP behavior, and documentation practices

Minimum Qualifications

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

Experience: Minimum 5 - 7 or more years of Quality Assurance experience in pharmaceutical manufacturing

Working knowledge of FDA 21 CFR Parts 210, 211, and cGMP regulations

Demonstrated experience developing and implementing quality systems

Internal audit experience (planning, execution, and reporting)

Strong documentation, investigation, and problem-solving skills

Preferred Qualifications

Experience in a startup, CDMO, or contract manufacturing environment

Direct involvement with FDA inspections

Experience supporting cleanroom or aseptic manufacturing operations

Familiarity with electronic QMS systems

Ability to work independently with minimal oversight

Physical & Work Environment Requirements

Lifting, standing, walking, or equipment use requirements

Ability to perform essential job functions with or without reasonable accommodation

Work environment may include (office, warehouse, manufacturing, lab, etc.

At-Will Employment Statement

Employment with VictoGen is at will, which means that either the employee or VictoGen may terminate the employment relationship at any time, with or without cause or notice, in accordance with applicable law.

VictoGen is anEqual Opportunity Employer. We are committed to providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, ancestry, age, disability, medical condition, genetic information, marital status, veteran status, or any other protected characteristic under applicable federal, state, or local laws.

Compensation is commensurate with experience, qualifications, and job scope.

VictoGen offers a competitive benefits package which may include:

Medical, dental, and vision insurance

Paid time off, holidays, and sick leave

Professional development and training opportunities

Additional benefits based on role and eligibility

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Worksite address

simi valley, CA, 93097, US

Who can apply

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