Quality Assurance Operations Supervisor (Pharmaceutical Manufacturing)

Location: Onsite in Irvine, California, United States; 2nd shift, 2:00 PM–10:30 PM

Salary: $80,000–$95,000 annually

Company

hirify.global is a global pharmaceutical contract development and manufacturing organization (CDMO) developing and manufacturing APIs and finished dosage forms across 16 sites and three continents.

What you will do

• Supervise, mentor, and develop QA Technicians and QA Associates supporting second-shift operations.
• Manage staffing, work assignments, priorities, and shift handoffs while building accountability and continuous improvement.
• Provide real-time quality oversight for formulation, compounding, filling, visual inspection, and packaging.
• Perform in-process verifications, line clearances, operational observations, batch record reviews, and oversight of aseptic techniques and gowning practices.
• Support investigations, deviations, CAPAs, root cause analysis, data integrity, and inspection readiness.
• Represent Quality during client audits, customer visits, and regulatory inspections while partnering with Manufacturing, Engineering, Validation, Microbiology, and Quality Systems.

Requirements

• Bachelor’s degree in Biology, Chemistry, Biochemistry, Engineering, or a related scientific discipline.
• 4–6 years of experience in Quality Assurance, Quality Operations, or pharmaceutical, biotechnology, or other GMP-regulated manufacturing.
• Supervisory, team lead, or people leadership experience.
• Strong understanding of cGMP requirements, FDA regulations, quality systems, SOPs, data integrity, and sterility assurance.
• Excellent communication, coaching, problem-solving, decision-making, and risk-based quality judgment.
• Ability to work onsite in Irvine on the second shift.

Nice to have

• Experience with sterile and aseptic manufacturing, pharmaceutical CDMO operations, or Grade A–D cleanrooms.
• Knowledge of EU GMP and Annex 1 requirements.
• Familiarity with TrackWise, SAP, LIMS, or other electronic quality systems.
• Experience supporting client audits, customer visits, and regulatory inspections.

Culture & Benefits

• Medical, dental, vision, and life insurance.
• Voluntary accident, hospital, and pet insurance.
• 401(k) plan.
• PTO, holidays, sick leave, and personal time.
• Collaborative environment focused on quality, safety, sustainability, and professional growth.