Sr. Specialist, Quality IT (Biotech)

Location: Hybrid role based in Bridgewater, New Jersey, United States; applicants must be authorized to work in the United States.

Salary: $83,711–$109,870 USD base pay annually, plus performance-based bonus and/or equity where applicable.

Company

hirify.global is a global biotechnology company developing cell therapies, including CAR-T, TCR-T, and NK cell-based approaches, and jointly developing and commercializing CARVYKTI® with Johnson & Johnson.

What you will do

• Provide IT Quality oversight for GxP system implementations, enhancements, upgrades, validation activities, change controls, and lifecycle management.
• Review validation plans, risk assessments, requirements, test protocols and reports, traceability matrices, release documentation, and retirement records.
• Partner with IT, Quality, Validation, business stakeholders, system owners, and suppliers on compliant system operation, maintenance, upgrades, and issue resolution.
• Support SOPs, work instructions, templates, standards, risk controls, and continuous improvement for GxP computerized systems.
• Investigate system issues, deviations, data-integrity concerns, and recurring error trends; support root-cause analysis, CAPAs, remediation, and audit-observation tracking.
• Support supplier qualification, audits, periodic reviews, access reviews, backup and recovery evidence, security and audit-trail reviews, regulatory inspections, and inspection readiness.

Requirements

• Bachelor’s degree in Science, Information Technology, Engineering, or an equivalent technical discipline.
• At least 7 years of relevant experience in the pharmaceutical, biotechnology, or medical-device industry, including at least 4 years supporting Quality Assurance, computerized system validation or assurance, IT Quality, or regulated computerized-system lifecycle activities.
• Working knowledge of global GxP requirements for computerized systems, including FDA 21 CFR Part 11, EU Annex 11, data integrity, and GAMP 5.
• Experience reviewing or authoring risk assessments, requirements, test protocols, traceability matrices, validation reports, change controls, deviations, and CAPAs.
• Experience with one or more enterprise or regulated platforms such as QMS, document management, validation management, change control, LIMS, Veeva, ERP, or SAP.
• Ability to apply risk-based CSV/CSA principles and translate compliance requirements into practical actions.
• Strong technical writing, documentation-review, analytical, problem-solving, communication, and collaboration skills.
• Ability to prioritize and manage multiple concurrent assignments while maintaining documentation quality and meeting commitments, with limited day-to-day supervision.
• Applicants must be authorized to work in the United States and complete Form I-9 and E-Verify employment verification if selected.

Nice to have

• Advanced degree or relevant professional certification.
• Experience supporting audits or regulatory inspections.
• Experience with clinical systems.

Culture & Benefits

• Permanent full-time employees receive medical, dental, and vision insurance, a 401(k) plan with company match, and paid time off.
• 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, insurance coverage, legal assistance, commuter benefits, family-care resources, well-being initiatives, and recognition programs.
• Contractors are not eligible for benefits through hirify.global.