Quality Manager – Pharmaceutical Manufacturing (Startup Environment)

New Horizon Medical Solutions LLC.; Simi Valley (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

VictoGen in California is seeking an experienced Quality Manager to build and maintain a compliant QMS and drive quality across manufacturing, lab, and support functions.

You will own internal audits, CAPA programs, deviations, change controls, and supplier quality, partnering with Operations, Manufacturing, and R&D to enable scale in a startup environment.

Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, or related field.
• 10+ years in pharmaceutical QA/QA Assurance in manufacturing.
• Knowledge of FDA 21 CFR Parts 210, 211 and cGMP.
• Experience developing and implementing quality systems.
• Experience with internal audits.

Responsibilities

• Develop, implement, and maintain a QMS compliant with FDA 21 CFR Parts 210/211.
• Author and approve SOPs, batch records, and controlled documents.
• Lead internal audits and prepare for FDA inspections; manage CAPAs.
• Oversee deviations, change controls, investigations, and training programs.
• Collaborate across Operations, Manufacturing, and R&D to scale quality as the company grows.
• Mentor staff on GMP practices and documentation.

Skills

Quality Assurance

Regulatory knowledge

Auditing

Documentation

Education

Bachelor’s degree in Life Sciences

Tools

Electronic QMS

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