CQV Supervisor (Cell Therapy)

Location: Raritan, New Jersey, United States

Base pay: $110,706–$145,303 per year

Company

hirify.global is a biotechnology company developing cell therapies, including CAR-T, TCR-T, and natural killer cell-based therapies, with a collaboration with Johnson & Johnson on CARVYKTI.

What you will do

• Lead commissioning, qualification, requalification, and validation activities for facilities, utilities, manufacturing and laboratory equipment, computerized systems, automation platforms, and manufacturing processes.
• Plan and manage multiple concurrent CQV projects while coordinating with Engineering, Manufacturing, Quality, Facilities, Automation, Information Technology, vendors, and contractors.
• Author, review, approve, and execute validation plans, protocols, reports, risk assessments, FMEAs, traceability documentation, and related lifecycle records.
• Lead investigations, root cause analyses, deviations, nonconformances, CAPAs, remediation plans, and change control activities.
• Maintain qualification and requalification programs to keep GMP systems and equipment in a validated state.
• Represent CQV during internal, customer, and regulatory audits and provide technical guidance and mentorship to CQV personnel and stakeholders.

Requirements

• Bachelor’s degree in engineering, life sciences, pharmaceutical sciences, biotechnology, chemistry, microbiology, or a related technical discipline.
• At least 8 years of progressive experience in CQV, Quality, Engineering, Manufacturing, or Compliance within a regulated pharmaceutical, biotechnology, cell therapy, or medical device environment.
• Expertise in FDA and global requirements, including 21 CFR Parts 11, 58, 210, 211, and 1271, EU GMP Annexes 11 and 15, GAMP 5, EudraLex, and applicable ICH guidelines.
• Experience with GMP systems, validation documentation, inspections, audits, investigations, CAPAs, change controls, remediation, and lifecycle management.
• Experience in aseptic manufacturing is highly preferred; cell therapy, CAR-T, biologics, tissue processing, quality assurance, or manufacturing compliance experience is highly desirable.
• Applicants must be authorized to work in the United States; employment eligibility will be verified through Form I-9 and E-Verify.

Nice to have

• Advanced degree or relevant professional certification.
• Up to 3 years of leadership or supervisory experience.
• Experience with Maximo, Siemens EMS, Comet, Kneat, Summit, electronic validation systems, or quality management systems.

Culture & Benefits

• Permanent full-time employees receive medical, dental, and vision insurance.
• Benefits include a 401(k) plan with company match, paid parental leave, paid time off, and company holidays.
• Additional benefits include flexible spending and health savings accounts, disability coverage, life insurance, commuter benefits, family-care resources, and well-being programs.
• Performance-based bonus and/or equity may be available for eligible roles.
• Benefits are available exclusively to permanent full-time employees; contractors are not eligible for hirify.global benefits.