QA Operations Manager — GMP Cell Therapy Leader

Iovance Biotherapeutics, Inc.; Philadelphia (Philadelphia County); On-site; USD 120,000 - 180,000; Full time

Job summary

Iovance Biotherapeutics, Inc. is seeking a Manager, QA Operations to support day-to-day GMP QA activities for iPBMC manufacturing and release. The role leads the internal QA team on-site and communicates across functions to ensure compliant, timely results.

Ideal candidates have 8+ years in biopharma QA, 5+ years in leadership, and strong CFR/GMP knowledge, with a focus on continuous improvement and regulatory readiness.

Qualifications

• Minimum BA/BS in scientific or technical field.
• 8+ years in biopharma GMP quality operations.
• At least 5 years of lead/supervisory QA experience in manufacturing.
• Strong understanding of CFR 21 CFR 210/211 and related GMP practices.
• Excellent written and verbal communication and collaboration skills.
• Proven ability to train and mentor QA staff and drive improvements.

Responsibilities

• Oversee day-to-day QA Operations activities and lot disposition.
• Interact with CMOs and internal teams to enable timely batch release.
• Contribute to decisions based on QA principles and data.
• Identify and implement new approaches for efficiency and quality.
• Review and approve release documentation and investigations.
• Document standard work, SOPs, deviations, CAPAs, and changes.
• Support internal audits and regulatory inspections.

Skills

QA Leadership

GMP/cGMP Knowledge

QA Documentation

Regulatory Compliance

Mentoring / Training

Cross-functional Collaboration

Quality Systems

Problem Solving

Education

BA/BS in Biological/Physical/Chemical sciences, engineering, or related field

Tools

Electronic QMS

Microsoft Office

Document Control Software

Job description

Iovance Biotherapeutics, Inc. is seeking a Manager, QA Operations to support day-to-day GMP QA activities for iPBMC manufacturing and release. The role leads the internal QA team on-site and communicates across functions to ensure compliant, timely results.

Ideal candidates have 8+ years in biopharma QA, 5+ years in leadership, and strong CFR/GMP knowledge, with a focus on continuous improvement and regulatory readiness.