CQV Supervisor (Cell Therapy)

Location: Raritan, New Jersey, United States; onsite

Salary: $110,706–$145,303 USD base pay per year, 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 natural killer cell-based therapies for serious diseases.

What you will do

• Execute commissioning, qualification, requalification, validation, and maintenance activities for facility, equipment, systems, and processes.
• Manage complex CQV projects and coordinate with technical operations, quality, manufacturing, contractors, and vendors.
• Author, own, and execute CQV protocols, summary reports, master plans, risk assessments, FMEAs, and related documentation.
• Support technical and quality investigations, deviations, CAPAs, corrections, remediation activities, and change controls.
• Present CQV activities during regulatory and internal audits and make decisions on corrective actions and technical approaches.
• Train and support junior CQV team members.

Requirements

• Bachelor’s degree in science, engineering, or an equivalent technical discipline.
• At least 7 years of relevant experience, preferably in aseptic manufacturing, cell therapy, testing, quality assurance, or manufacturing compliance.
• Detailed knowledge of cGMP and cGTP requirements related to CAR-T manufacturing or cell processing.
• Experience with ICH and 21 CFR Parts 210, 211, and 1271; experience with Parts 600, 601, and 610 is preferred.
• Experience authoring and executing batch records, SOPs, work instructions, and CQV protocols.
• Working knowledge of Maximo, Siemens EMS, Comet, Kneat, Kaye AVS, or Kaye Valprobe, plus strong communication, organizational, analytical, and collaboration skills.
• Applicants must be authorized to work in the United States; employment eligibility is verified through Form I-9 and E-Verify.
• English is required.

Culture & Benefits

• Permanent full-time employment with 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 vacation, personal and sick time, floating holidays, and eleven company holidays.
• Additional benefits include flexible spending and health savings accounts, disability coverage, life insurance, commuter benefits, family-care resources, and well-being programs.
• Benefits are available exclusively to permanent full-time employees; contractors are not eligible.