Associate Director, Quality Systems
Legend Biotech
August 26, 2026
On-site
Raritan, NJ
Operations
Associate Director, Quality Systems (Raritan, NJ)
Role Overview
- Quality systems oversight within a cell therapy manufacturing plant in a sterile GMP environment. Lead a team managing document control, investigations, CAPA, change control, site quality metrics, and laboratory QA oversight; support inspection readiness and regulatory inspections.
Key Responsibilities
- Oversee Quality Systems, Systems Support, and Investigations to meet goals/deadlines.
- Lead and continuously improve Quality Risk Management (QRM); facilitate cross-functional risk assessments (e.g., FMEA/hazard analyses).
- Ensure risks from investigations, deviations, CAPAs, and changes are assessed, documented, monitored through closure.
- Monitor quality trends, recurring events, backlog/aging/recurrence/effectiveness metrics; develop KPIs/dashboards.
- Provide expert guidance for complex/high-risk/Critical/OOS investigations; review/approve complex investigations, CAPAs, corrections, and effectiveness checks.
- Drive investigation excellence, lead governance forums, coach teams, and guide interpretation of quality issues.
- Partner cross-functionally (Manufacturing, QC, Engineering, Supply Chain, Tech Ops, QA/Validation/Compliance) for harmonized, risk-based decisions.
- Act as Investigation Governance SME during audits/inspections.
Requirements
- Bachelor’s degree in a relevant technical field (advanced degree preferred).
- 10+ years Quality experience in cGMP manufacturing/biopharma/Cell & Gene Therapy; sterile manufacturing preferred. Proven leadership of quality systems, complex investigations, CAPA/governance/quality improvement, cross-functional projects, and inspection/audit readiness.
Benefits (selected)
- Base pay: $146,410–$192,164 (USD); performance bonus/equity (eligible roles).
- Medical/dental/vision; 401(k) match (vests day one).
- 8 weeks paid parental leave after 3 months; PTO incl. vacation/personal/sick/floating holidays + 11 company holidays.
Employment Eligibility
- Must be authorized to work in the United States (E-Verify; I-9 required).
Role Overview
- Quality systems oversight within a cell therapy manufacturing plant in a sterile GMP environment. Lead a team managing document control, investigations, CAPA, change control, site quality metrics, and laboratory QA oversight; support inspection readiness and regulatory inspections.
Key Responsibilities
- Oversee Quality Systems, Systems Support, and Investigations to meet goals/deadlines.
- Lead and continuously improve Quality Risk Management (QRM); facilitate cross-functional risk assessments (e.g., FMEA/hazard analyses).
- Ensure risks from investigations, deviations, CAPAs, and changes are assessed, documented, monitored through closure.
- Monitor quality trends, recurring events, backlog/aging/recurrence/effectiveness metrics; develop KPIs/dashboards.
- Provide expert guidance for complex/high-risk/Critical/OOS investigations; review/approve complex investigations, CAPAs, corrections, and effectiveness checks.
- Drive investigation excellence, lead governance forums, coach teams, and guide interpretation of quality issues.
- Partner cross-functionally (Manufacturing, QC, Engineering, Supply Chain, Tech Ops, QA/Validation/Compliance) for harmonized, risk-based decisions.
- Act as Investigation Governance SME during audits/inspections.
Requirements
- Bachelor’s degree in a relevant technical field (advanced degree preferred).
- 10+ years Quality experience in cGMP manufacturing/biopharma/Cell & Gene Therapy; sterile manufacturing preferred. Proven leadership of quality systems, complex investigations, CAPA/governance/quality improvement, cross-functional projects, and inspection/audit readiness.
Benefits (selected)
- Base pay: $146,410–$192,164 (USD); performance bonus/equity (eligible roles).
- Medical/dental/vision; 401(k) match (vests day one).
- 8 weeks paid parental leave after 3 months; PTO incl. vacation/personal/sick/floating holidays + 11 company holidays.
Employment Eligibility
- Must be authorized to work in the United States (E-Verify; I-9 required).