Associate Director, Quality Systems (Biotechnology)

Location: Onsite in Raritan, New Jersey, United States

Base pay: $146,410–$192,164 USD per year, plus performance-based bonus and/or equity for eligible roles.

Company

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

What you will do

• Provide quality systems oversight for a commercial CAR-T manufacturing site operating in a sterile GMP environment.
• Lead Quality Systems, Systems Support, and Investigations teams, including document control, deviations, CAPA, change control, and laboratory QA oversight.
• Lead quality risk management activities, including FMEA, hazard analysis, impact assessments, risk mitigation, and control effectiveness reviews.
• Direct complex, high-risk, critical, and OOS investigations, root cause analysis workshops, CAPA approvals, and effectiveness checks.
• Develop quality metrics, dashboards, KPIs, governance forums, and performance management tools to monitor trends, backlog, aging, recurrence, and effectiveness.
• Partner with Manufacturing, Quality Control, Engineering, Supply Chain, Technical Operations, and other functions to improve compliance, inspection readiness, and quality processes.

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 & Gene Therapy environment.
• Experience leading quality systems, complex investigations, CAPA programs, governance programs, quality improvement initiatives, and cross-functional projects.
• Experience supporting regulatory inspection or audit readiness activities is required; sterile manufacturing experience is preferred.
• Applicants must already be authorized to work in the United States; employment eligibility is verified through Form I-9 and E-Verify.

Nice to have

• Advanced degree.
• Sterile manufacturing experience.

Culture & Benefits

• 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 voluntary benefits include flexible spending and health savings accounts, disability coverage, legal assistance, commuter benefits, and family care resources.