Manager, Quality Control (Cell Therapy)

Location: Bridgewater, New Jersey, United States; on-site

Company

hirify.global develops and manufactures cellular therapy products in a GMP environment.

What you will do

• Lead Quality Control analysts performing analytical testing of in-process, finished, and stability samples.
• Manage routine and non-routine laboratory analysis while maintaining GxP and safety standards.
• Review and approve Certificates of Analysis, analytical methods, validation protocols and reports, stability documentation, and QC procedures.
• Investigate OOS results and manage deviations, CAPAs, change controls, audits, and quality metrics.
• Manage analytical method validation, transfer methods to contract laboratories, and oversee equipment validation, calibration, maintenance, and troubleshooting.
• Represent Quality Control in cross-functional meetings, vendor interactions, regulatory data packages, and team development.

Requirements

• BA or BS in a science discipline or comparable experience; an MS in a scientific discipline is preferred.
• At least 7 years of operational experience in a cGMP or cGxP pharmaceutical or biotech manufacturing environment.
• At least 2 years of experience in a managerial role.
• Strong background in cell biology, immunology, molecular biology, and associated analytical assays.
• Working knowledge of quality systems, regulatory requirements including 21 CFR Part 11/210/211, controlled documentation, cGMPs, SOPs, analytical testing, and auditing.
• Experience with OOS, deviation reports, CAPAs, and equipment IQ/OQ/PQ qualification.

Nice to have

• Experience with analytical method development and validation.
• MS Office proficiency, including Word, Excel, Outlook, and PowerPoint.

Culture & Benefits

• Fast-paced, mission-driven environment focused on cell and gene therapy.
• Opportunity to build and grow a phase-appropriate Quality Control team.
• Work requires collaboration across departments, vendors, contractors, and contract laboratories.
• Leveling is based on overall experience, education, and demonstrated knowledge during the interview process.