Manager III, Quality Assurance (Product Release) (Pharmaceutical Manufacturing)

Location: Onsite in Irvine, California, United States. Relocation is not available.

Salary: $139,000–$173,000 per year

Company

hirify.global develops, manufactures, and markets healthcare products and services, including infusion therapy, pain management, nutrition, pharmacy compounding, ostomy and wound care, and dialysis solutions.

What you will do

• Lead and develop a QA Product Release team of 10–15 quality professionals.
• Plan, prioritize, and assign batch review and product release activities.
• Partner with Manufacturing, Planning, QC Laboratories, and other cross-functional teams.
• Ensure compliance with FDA regulations, GMP requirements, and company quality standards.
• Support FDA inspections, regulatory audits, and inspection readiness.
• Drive operational excellence through coaching, conflict resolution, employee development, and collaboration.

Requirements

• Bachelor’s degree in a scientific discipline required; a Master’s degree or higher is preferred.
• 10+ years of Quality Assurance experience in a pharmaceutical or biotech manufacturing environment.
• Extensive experience with batch record review and product release.
• Strong knowledge of FDA regulations, including 21 CFR Parts 210, 211, and Part 11, GMPs, and pharmaceutical manufacturing processes.
• Experience supporting FDA audits and regulatory inspections.
• Proven leadership experience managing large teams and driving accountability, collaboration, and continuous improvement.

Culture & Benefits

• Onsite Monday through Friday schedule with a 5x8 shift.
• Healthcare benefits.
• 401(k) plan.
• Tuition reimbursement.
• Focus on continuous improvement and sharing expertise across healthcare products and services.