Sr. Manager Quality IT (Biotech)

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

Salary: $127,313–$167,099 USD base pay per year, with performance-based bonus and/or equity available for eligible roles.

Company

hirify.global is a biotechnology company developing cell therapies, including CAR-T, TCR-T, and natural killer cell-based therapies.

What you will do

• Provide IT Quality oversight for GxP system implementation, validation, enhancements, lifecycle management, and change control.
• Ensure computerized systems, electronic records, electronic signatures, and data processes comply with global GxP, cGMP, GCP, GLP, FDA, EU, MHRA, and GAMP5 requirements.
• Develop and coordinate validation plans, qualification protocols and reports, risk assessments, SOPs, and requirements traceability matrices.
• Review system changes, error reports, deviations, CAPAs, and audit observations while driving remediation and data integrity.
• Support supplier audits, inspection readiness, regulatory inspections, quality metrics, and continuous improvement initiatives.
• Train IT personnel and stakeholders and establish relationships across Quality, IT, functional leadership, and project management teams.

Requirements

• Bachelor’s degree in Science, IT, Engineering, or an equivalent technical discipline; an advanced degree is preferred.
• 10+ years of relevant experience in the pharmaceutical, biotechnology, or medical device industry, including at least 5 years of leadership experience.
• Experience in Quality Assurance, Quality Systems, and/or IT, with strong knowledge of global GxP regulations; US regulations are required.
• Proficiency with QMS software, document control, validation tools, change control systems, LIMS, Veeva, and ERP systems.
• Ability to communicate compliance requirements clearly, apply risk-based approaches, manage multiple projects, and collaborate with internal and external stakeholders.
• US work authorization is required.

Nice to have

• Experience with SAP, EU, China, and GTP requirements.
• Firsthand regulatory agency inspection experience.
• Clinical, GMP, and GLP audit experience.

Culture & Benefits

• Permanent full-time employees receive medical, dental, and vision insurance.
• 401(k) retirement plan with company match fully vested from day one.
• Eight weeks of paid parental leave after three months of employment.
• Paid time off includes vacation, personal and sick time, floating holidays, 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.