Director, QA Operations
Legend Biotech
September 02, 2026
On-site
Raritan, NJ
Operations
Role Overview
Director of Quality Operations, CAR-T provides Quality oversight and support for cell therapy manufacturing operations in full compliance with cGMP. Supports disposition (incoming materials and final drug product), QA shop-floor oversight, QA review/approval, and QC laboratory oversight. Develops and executes long-term Quality programs, trends quality operations metrics, drives continuous improvement, and manages a team of QA people leaders and technical professionals.
Key Responsibilities
- Manage daily quality activities to ensure facility, process, and materials comply with cGMP.
- Align Quality Policies, Guidelines, Programs, and Systems with other functional leaders.
- Lead incoming and final product disposition.
- Oversee batch record review.
- Manage quality shop-floor activities for manufacturing compliance.
- Provide quality oversight of the QC laboratory.
- Drive continuous improvement in organizational agility.
- Lead, hire, and develop Quality team members.
- Coordinate quality systems activities across departments, sites, and companies.
- Perform work consistent with safety, Quality systems, and cGMP.
Requirements
- Bachelor’s degree in Science/Information Science or equivalent.
- 14+ years relevant experience (preferred aseptic manufacturing and/or QA, manufacturing compliance, clinical quality, or cell therapy).
- cGMP and FDA/EU guidance knowledge; Good Tissue Practices.
- Strong communication; proven people management/leadership.
- Quality systems experience; strong chemical/biochemical/microbiology knowledge.
- Preferred: aseptic ISO 5 clean room and biosafety cabinet experience.
- Ability to make critical decisions with limited info; manage shifting priorities.
- Process excellence tools; highly organized/team-oriented.
- Experience with ICH and/or 21 CFR 210, 211, 1271 (preferred 600/601/610).
- Proficient in Microsoft Office.
Benefits (highlights)
Base pay: $193,629–$254,137. Medical/dental/vision, 401(k) match, 8 weeks paid parental leave (after 3 months), paid time off, and additional voluntary benefits.
Director of Quality Operations, CAR-T provides Quality oversight and support for cell therapy manufacturing operations in full compliance with cGMP. Supports disposition (incoming materials and final drug product), QA shop-floor oversight, QA review/approval, and QC laboratory oversight. Develops and executes long-term Quality programs, trends quality operations metrics, drives continuous improvement, and manages a team of QA people leaders and technical professionals.
Key Responsibilities
- Manage daily quality activities to ensure facility, process, and materials comply with cGMP.
- Align Quality Policies, Guidelines, Programs, and Systems with other functional leaders.
- Lead incoming and final product disposition.
- Oversee batch record review.
- Manage quality shop-floor activities for manufacturing compliance.
- Provide quality oversight of the QC laboratory.
- Drive continuous improvement in organizational agility.
- Lead, hire, and develop Quality team members.
- Coordinate quality systems activities across departments, sites, and companies.
- Perform work consistent with safety, Quality systems, and cGMP.
Requirements
- Bachelor’s degree in Science/Information Science or equivalent.
- 14+ years relevant experience (preferred aseptic manufacturing and/or QA, manufacturing compliance, clinical quality, or cell therapy).
- cGMP and FDA/EU guidance knowledge; Good Tissue Practices.
- Strong communication; proven people management/leadership.
- Quality systems experience; strong chemical/biochemical/microbiology knowledge.
- Preferred: aseptic ISO 5 clean room and biosafety cabinet experience.
- Ability to make critical decisions with limited info; manage shifting priorities.
- Process excellence tools; highly organized/team-oriented.
- Experience with ICH and/or 21 CFR 210, 211, 1271 (preferred 600/601/610).
- Proficient in Microsoft Office.
Benefits (highlights)
Base pay: $193,629–$254,137. Medical/dental/vision, 401(k) match, 8 weeks paid parental leave (after 3 months), paid time off, and additional voluntary benefits.