Director, QA Operations (CAR-T)

Location: Raritan, New Jersey, United States; onsite. Applicants must be authorized to work in the United States.

Salary: $193,629–$254,137 USD base pay annually, plus performance-based bonus and/or equity for eligible roles.

Company

hirify.global is a biotechnology company developing cell therapies, including CAR-T, TCR-T, and NK cell-based treatments for serious diseases.

What you will do

• Lead daily quality activities for facility, process, materials, and manufacturing operations in compliance with cGMP requirements.
• Oversee incoming material and final product disposition, batch record review, and quality assurance approvals.
• Direct quality shop-floor oversight of manufacturing operations and quality oversight of the QC laboratory.
• Develop and execute long-term quality programs, trend operational metrics, and implement continuous improvement initiatives.
• Manage senior managers and technical professionals, including hiring, coaching, and capability development.
• Coordinate quality systems activities across departments, sites, companies, and business units.

Requirements

• Bachelor’s degree in Science, Information Science, or an equivalent technical discipline.
• At least 14 years of relevant work experience, preferably in aseptic manufacturing, quality assurance, manufacturing compliance, clinical quality, or cell therapy.
• Knowledge of cGMP regulations, FDA/EU guidance for cell-based products, and Good Tissue Practices.
• Proven people management and leadership experience, with experience working with quality systems.
• Experience with ICH and 21 CFR Parts 210, 211, and 1271; knowledge of Parts 600, 601, and 610 is preferred.
• Ability to process complex information, make critical decisions, manage shifting priorities, apply process excellence methods, and remediate process or system gaps.

Nice to have

• Experience in an aseptic manufacturing facility, ISO 5 clean rooms, and biosafety cabinets.
• Experience in cell therapy manufacturing.
• Knowledge of 21 CFR Parts 600, 601, and 610.

Culture & Benefits

• Medical, dental, and vision insurance.
• 401(k) retirement plan with company match fully vested on day one.
• Eight weeks of paid parental leave after three months of employment.
• Paid time off including vacation, personal and sick time, floating holidays, and eleven company holidays.
• Additional benefits include flexible spending and health savings accounts, disability coverage, legal assistance, commuter benefits, family-care resources, and well-being programs.
• Benefits are available exclusively to permanent full-time employees; contractors are not eligible.