Associate Director, Quality Systems (Biotechnology)

Location: Onsite in Raritan, New Jersey, United States

Base pay: $146,410–$192,164 USD annually, 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 NK cell-based treatments.

What you will do

• Oversee quality systems, systems support, investigations, document control, CAPA, change control, quality metrics, and laboratory QA for a CAR-T manufacturing site.
• Lead quality risk management, cross-functional risk assessments, and mitigation activities across site operations.
• Provide expert guidance for complex, high-risk, critical, and OOS investigations, including root cause analysis and effectiveness checks.
• Monitor investigation and CAPA trends, backlogs, aging, recurrence, and effectiveness through dashboards, KPIs, and governance forums.
• Partner with Manufacturing, Quality Control, Engineering, Supply Chain, Technical Operations, and other functions to improve processes and compliance.
• Support audits and regulatory inspections as the Quality Systems and Investigation Governance subject matter expert.

Requirements

• Bachelor’s degree in Science, Engineering, Biotechnology, Pharmacy, Information Science, Biology, or a related technical discipline.
• At least 10 years of quality experience in a cGMP-regulated manufacturing, biotechnology, biopharmaceutical, or cell and gene therapy environment.
• Experience leading quality systems, complex investigations, CAPA programs, governance programs, quality improvement initiatives, and cross-functional projects.
• Experience with regulatory inspection or audit readiness activities; sterile manufacturing experience is preferred.
• Applicants must be authorized to work in the United States; employment eligibility is verified through Form I-9 and E-Verify.

Culture & Benefits

• Permanent full-time employees receive medical, dental, and vision insurance.
• 401(k) retirement plan with a company match that fully vests on day one.
• Eight weeks of paid parental leave after three months of employment.
• Paid vacation, personal time, sick time, floating holidays, and eleven company holidays.
• Additional benefits include flexible spending and health savings accounts, disability coverage, life insurance, commuter benefits, and family care resources.