Director of QA Operations, CAR‑T

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

Benefits offered by this job

Medical insurance

Dental insurance

401(k) with company match

Paid parental leave

Paid time off

Job summary

Qualifications

• Bachelor’s degree in science or equivalent required.
• Minimum 14 years of relevant experience; aseptic manufacturing preferred.
• Knowledge of cGMP, FDA/EU guidance for cell-based products, and Good Tissue Practices.
• Strong communication and leadership capabilities.
• Experience with quality systems and team leadership.
• ICH and 21 CFR Part 210, 211, 1271; 600, 601, 610 preferred.
• Proficiency with Microsoft Office tools.

Responsibilities

• Manage daily quality activities for the QA operations team to ensure cGMP compliance.
• Partner with Legend leaders to align with Quality Policies and Systems.
• Oversee incoming and final product disposition for the site.
• Oversee batch record review activities for the site.
• Quality shop floor program oversight for manufacturing operations.
• Provide quality oversight of the QC laboratory.
• Develop and implement continuous improvement in quality processes.
• Lead and develop senior managers and professionals within QA.

Skills

Communication

People management

GMP knowledge

Quality systems

Leadership

Aseptic processing

Microsoft Office

Education

Bachelor's degree in a scientific field

Tools

Microsoft Office (Outlook, Excel, Word, PowerPoint)

Job description