Senior QA Ops Manager, GMP Biopharma

Wwshemi; Philadelphia (Philadelphia County); On-site; USD 120,000 - 170,000; Full time

Job summary

Iovance Biotherapeutics in Philadelphia is hiring a Manager of Quality Assurance (QA Ops) to oversee day-to-day GMP QA activities supporting manufacturing, testing, and release of iPBMCs. The role requires strong leadership, regulatory knowledge, and cross-functional collaboration on-site.

The successful candidate will review documentation, manage QA staff, ensure cGMP compliance, and support internal audits and inspections in a fast-paced environment.

Qualifications

• BA/BS or equivalent in Biological, physical, chemical sciences, engineering, or related field.
• Minimum 8 years in biopharma GMP QA operations, including cell culture.
• At least 5 years leading QA teams in a manufacturing environment.
• Comprehensive understanding of QA processes, regulatory requirements for cGMP.
• Experience leading development initiatives, training, coaching.

Responsibilities

• Provide QA operations support for day-to-day activities and lot disposition.
• Review/approve qualification and validation documentation and CAPAs.
• Interact with CMOs and internal teams to ensure timely batch release.
• Mentor QA staff and manage performance reviews.
• Maintain QA records and enforce regulatory compliance.
• Support internal audits and regulatory inspections.

Skills

Quality Assurance

Leadership

Regulatory knowledge

Documentation

Problem solving

Education

BA/BS in science/engineering

Tools

Microsoft Office Suite

Word

Excel

PowerPoint

Job description

Iovance Biotherapeutics in Philadelphia is hiring a Manager of Quality Assurance (QA Ops) to oversee day-to-day GMP QA activities supporting manufacturing, testing, and release of iPBMCs. The role requires strong leadership, regulatory knowledge, and cross-functional collaboration on-site.

The successful candidate will review documentation, manage QA staff, ensure cGMP compliance, and support internal audits and inspections in a fast-paced environment.