Associate Director, Quality Systems & Compliance

Merck & Co.; Raritan (NJ); On-site; USD 146,000 - 192,000; Full time

Benefits offered by this job

Medical insurance

401(k) match

Parental leave

Paid time off

Job summary

Legend Biotech, based in New Jersey, seeks an Associate Director, Quality Systems for the Raritan site to lead quality systems oversight in a sterile GMP environment. You will manage a team handling DOC control, investigations, CAPA, change control, site quality metrics, and QA oversight, while supporting regulatory inspections and readiness.

The role requires strong leadership, 10+ years in quality within cGMP manufacturing, and collaboration with cross‑functional partners to ensure compliant,

Qualifications

• Bachelor's degree in Science, Engineering, Biotechnology, Pharmacy, Information Science, Biology, or related technical discipline.
• Advanced degree preferred.

Responsibilities

• Provide quality systems oversight for the CAR‑T manufacturing site.
• Oversee investigations, CAPA, and change control to meet goals and deadlines.
• Lead quality risk management processes and site inspection readiness.

Skills

Quality Systems oversight

CAPA

Investigations

Change control

Education

Bachelor's degree

Tools

GMP

Job description

Legend Biotech, based in New Jersey, seeks an Associate Director, Quality Systems for the Raritan site to lead quality systems oversight in a sterile GMP environment. You will manage a team handling DOC control, investigations, CAPA, change control, site quality metrics, and QA oversight, while supporting regulatory inspections and readiness.

The role requires strong leadership, 10+ years in quality within cGMP manufacturing, and collaboration with cross‑functional partners to ensure compliant,