About this opportunity
New Horizon Medical Solutions LLC. lists this Quality Manager – Pharmaceutical Manufacturing (Startup Environment) opportunity in simi valley, California. Review the employer’s description below for duties, qualifications and application requirements.
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 Manager 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 Manager 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 10 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
Review the original listing for work authorization, qualifications and employer requirements.