QA Cryo Lead - CAR-T & QA Leadership (Beerse)

7555-Janssen Pharmaceutica NV Legal Entity; Geel; On-site; EUR 73,000 - 115,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Job summary

Johnson & Johnson Beerse is recruiting a QA Cryo Lead for the CAR-T Cryopreservation Center. The role oversees QA in a high‑stakes, cross‑functional environment, driving CAPA actions and ensuring regulatory compliance for CAR‑T processes.

You will lead a QA team, partner with Cryo Operations and IT, and manage GxP documentation while promoting continuous improvement and digital solutions in a fast‑changing biologics setting.

Qualifications

• Master’s degree in engineering or science with QA/GxP manufacturing experience.
• Minimum 5 years of relevant work experience.
• Prior experience in cell and gene therapy is preferred.
• Proficiency in English and Dutch, with strong communication skills in cross‑functional meetings.
• Supervisory experience is a plus.
• Knowledge of Tissues and Cells Directive, GTP, SOHO is advantageous.
• Leads by example and fosters inclusion and teamwork.
• Experience with batch record review, deviations, audits, validation, MES or Opstrakker is a strong asset.
• Comfort with a fully digital process flow and awareness of AI concepts.

Responsibilities

• Safeguard priorities and quality continuity; drive actions to completion.
• Lead, coach, and develop a QA team to meet objectives and performance.
• Oversee end-to-end QA for nonconformance and CAPA; drive risk-based decisions and ensure corrective actions.
• Support optimization of QA MES processes and digital improvements.
• Serve as primary QA contact for Cryo activities and collaborate with cross-functional teams.
• Ensure alignment of QA activities with Quality Management and regulatory requirements.
• Communicate progress clearly and timely; manage KPI-driven reporting.
• Coordinate GxP processes including batch release, deviations, changes, and documentation.

Skills

BPM

Req Analysis

Business Savvy

Coaching

Communication

Compliance Mgmt

Cross-Functional

Data Savvy

Fact-Based Decisions

ISO 9001

Operational Excellence

Problem Solving

Process Optimization

Quality Control

QMS

SOP

Education

Master’s degree in engineering/science

Tools

SAP

COMET

eLIMS

MES

Job description

Johnson & Johnson Beerse is recruiting a QA Cryo Lead for the CAR-T Cryopreservation Center. The role oversees QA in a high‑stakes, cross‑functional environment, driving CAPA actions and ensuring regulatory compliance for CAR‑T processes.

You will lead a QA team, partner with Cryo Operations and IT, and manage GxP documentation while promoting continuous improvement and digital solutions in a fast‑changing biologics setting.