EMEA CAR-T QA Qualification Lead

Johnson & Johnson Co.; Oost-Vlaanderen; On-site; EUR 130,000 - 170,000; Full time

Job summary

Johnson & Johnson's Janssen CAR-T Europe hub in Ghent, Belgium seeks a QA Qualification Manager to oversee qualification across CAR-T manufacturing units. You will ensure regulatory compliance, lifecycle management of facilities and equipment, and QA support for expansion projects.

The role requires a senior QA professional with strong leadership, risk-based thinking, and the ability to interact with cross-functional teams and regulatory bodies in a dynamic biopharma setting.

Qualifications

• Strong analytical, risk-based decision-making and problem-solving skills required.
• Excellent written and verbal communication to diverse stakeholders.
• Demonstrated experience leading a QA team in pharma/biotech settings.

Responsibilities

• Lead the QA Qualification team overseeing facilities, utilities and production equipment for CAR-T manufacturing.
• Provide QA review/approval of qualification/validation deliverables and investigations.
• Serve as QA spokesperson during regulatory inspections and partner engagements.

Skills

Analytical

Communication

Leadership

Education

Bachelor's degree in engineering or Life Sciences

Job description

Johnson & Johnson's Janssen CAR-T Europe hub in Ghent, Belgium seeks a QA Qualification Manager to oversee qualification across CAR-T manufacturing units. You will ensure regulatory compliance, lifecycle management of facilities and equipment, and QA support for expansion projects.

The role requires a senior QA professional with strong leadership, risk-based thinking, and the ability to interact with cross-functional teams and regulatory bodies in a dynamic biopharma setting.