CQV Manager (Cell Therapy)

Location: Raritan, New Jersey, United States. Onsite role. Applicants must be authorized to work in the United States; employment eligibility is verified through E-Verify.

Base pay: $127,313–$167,099 USD per year. Performance-based bonus and/or equity may be available for eligible roles.

Company

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

What you will do

• Lead commissioning, qualification, requalification, and validation for facilities, utilities, manufacturing and laboratory equipment, computerized systems, automation platforms, and manufacturing processes.
• Plan, execute, and manage multiple concurrent CQV and CSV projects across their full lifecycle.
• Develop, review, approve, and execute validation plans, protocols, reports, periodic reviews, traceability documentation, risk assessments, FMEAs, and Validation Master Plans.
• Manage deviations, nonconformances, root cause analyses, CAPAs, change controls, remediation plans, and compliance improvements.
• Coordinate with Engineering, Manufacturing, Quality, Facilities, Automation, Information Technology, and external vendors and contractors.
• Represent CQV and CSV during internal, customer, and regulatory audits and inspections; provide technical guidance, coaching, and mentorship.

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/CSV, Quality, Engineering, Manufacturing, or Compliance within a regulated pharmaceutical, biotechnology, cell therapy, or medical device environment.
• At least 5 years of leadership or supervisory experience, including management of personnel, projects, contractors, and cross-functional teams.
• Expertise in FDA and global requirements, including 21 CFR Parts 11, 58, 210, 211, and 1271, EU GMP, EudraLex, EU GMP Annexes 11 and 15, GAMP 5, and applicable ICH guidelines.
• Knowledge of cGMP, cGTP, GMP data integrity, and regulations for cell and gene therapy, tissue-based, and cellular therapy products.
• Experience with regulatory inspections, internal audits, validation programs, investigations, CAPAs, change controls, remediation, and GMP system lifecycle management.
• Experience leading CQV activities for facilities, utilities, manufacturing equipment, laboratory systems, computerized systems, and automation platforms.
• Experience authoring, reviewing, approving, and executing VMPs, PVPs, risk assessments, FMEAs, IQ/OQ/PQ protocols, summary reports, technical impact assessments, SOPs, work instructions, change controls, and addenda.
• Strong project management, root cause analysis, investigation management, CAPA, continuous improvement, operational excellence, risk-based validation, communication, technical writing, presentation, decision-making, and stakeholder leadership skills.
• Experience with Maximo, Siemens EMS, Comet, Kneat, Summit, or equivalent validation and maintenance systems; proficiency with Microsoft Word, Excel, PowerPoint, Outlook, and Teams.
• Ability to work independently, lead multidisciplinary teams, influence stakeholders, manage competing priorities, and operate in a fast-paced environment.
• English language required.

Nice to have

• Advanced degree or relevant professional certification.
• Experience in aseptic manufacturing, cell therapy, CAR-T, biologics, tissue processing, quality assurance, or manufacturing compliance.
• Familiarity with electronic validation systems, quality management systems, and computerized system lifecycle management.

Culture & Benefits

• Permanent full-time employees receive medical, dental, and vision insurance and a 401(k) plan with company matching fully vested on day one.
• Benefits include eight weeks of paid parental leave after three months, vacation, personal and sick time, floating holidays, and eleven company holidays.
• Additional benefits include flexible spending and health savings accounts, life and disability insurance, legal assistance, supplemental insurance, commuter benefits, family planning and care resources, well-being initiatives, and peer recognition programs.
• Contractors are not eligible for benefits through hirify.global.