Director, QA Operations - Cell Therapy & cGMP Leader

Legendcareers; Raritan (NJ); On-site; USD 194,000 - 254,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) with company match

Parental Leave

Paid time off

Job summary

Legend Biotech is seeking a Director of QA Operations in Raritan, NJ. The role leads quality oversight of CAR-T manufacturing, including disposition, batch review, and QC oversight, ensuring strict cGMP compliance and robust quality programs.

The candidate will manage a senior team, develop continuous improvements, and partner across units to align quality with business goals. Strong leadership and regulatory knowledge are essential.

Qualifications

• Bachelor’s Degree in Science or equivalent technical discipline.
• 14+ years in aseptic manufacturing quality roles preferred.
• Knowledge of cGMP and FDA/EU guidance for cell therapy.
• Strong interpersonal and written/oral communication skills.
• Proven people management and leadership experience.
• Experience with quality systems.
• Expertise in chemical, biochemical and microbiological concepts.
• Experience with ISO 5 clean rooms and biosafety cabinets preferred.
• Ability to quickly process complex information and make decisions with limited data.
• Ability to manage multiple priorities with shifting priorities.
• Proficient with process excellence tools/methodologies.
• Organized, team-oriented, positive attitude.
• Strong summarization and presentation skills; collaboration.
• Experience developing long-term objectives.
• Ability to identify/remediate gaps in processes.
• Experience with ICH and/or 21 CFR parts 210,211,1271; 600,601,610 preferred.
• Proficient with MS Office (Outlook, Excel, Word, PowerPoint).

Responsibilities

• Manage daily quality activities for operations to ensure cGMP compliance.
• Partner with Legend leaders to align with Quality Policies, Guidelines, Programs and Systems.
• Responsible for all aspects of incoming and final product disposition for the site.
• Responsible for batch record review activities for the site.
• Oversees quality shop floor program for manufacturing operations.
• Quality oversight of the QC laboratory.
• Develop continuous improvement initiatives for team and processes.
• Manage a team of senior managers and professionals within Quality.
• Coordinate quality systems activities across functions and sites.
• Establish partnerships to link business processes effectively.

Skills

Quality assurance

Leadership

cGMP compliance

Regulatory knowledge

Process excellence

Communication

Team management

QA systems

Documentation

Quality metrics

Education

Bachelor’s Degree in Science or equivalent

Tools

MS Office

Quality systems software

Job description

Legend Biotech is seeking a Director of QA Operations in Raritan, NJ. The role leads quality oversight of CAR-T manufacturing, including disposition, batch review, and QC oversight, ensuring strict cGMP compliance and robust quality programs.

The candidate will manage a senior team, develop continuous improvements, and partner across units to align quality with business goals. Strong leadership and regulatory knowledge are essential.