Quality Lead I (Pharmaceutical Manufacturing)

Location: Irvine, California, United States; regular on-site attendance required. Schedule: Monday–Friday, 9:00 a.m.–5:30 p.m.; non-standard schedules may be required.

Company

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

What you will do

• Perform Quality Control Release Verifications and process Incident Reports for GMP-regulated manufacturing operations.
• Manage laboratory testing requirements and track completion before manufacturing rooms are released to production.
• Review manufacturing documentation, quality records, procedures, and testing requirements for completeness and compliance.
• Investigate quality issues, assess manufacturing risks, identify root causes, and support corrective actions.
• Coordinate quality activities with laboratory, manufacturing, engineering, and other cross-functional teams.
• Provide work direction, coaching, and training to Quality Operations Associates and escalate compliance risks when needed.

Requirements

• Bachelor’s degree in science, engineering, or a related technical field preferred, or six years of relevant experience in a GMP-regulated environment.
• Experience managing quality control and incident reports, manufacturing documentation, and quality system workflows.
• Strong understanding of GMP regulations, documentation practices, manufacturing processes, laboratory testing, and quality systems.
• Ability to interpret technical procedures, conduct investigations and research, and communicate across functional areas.
• Regular and predictable on-site attendance in Irvine, California is required.

Culture & Benefits

• Healthcare benefits and a 401(k) plan.
• Tuition reimbursement.
• Continuous improvement supported through the Sharing Expertise initiative.
• Focus on safety, knowledge sharing, innovation, efficiency, and sustainability.