QA Cryo Supervisor CAR-T

Biopharma Careers; Antwerpen; Hybrid; EUR 60,000 - 96,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Job summary

Johnson & Johnson seeks a QA Cryo Supervisor for the CAR-T Cryopreservation Center in Beerse, Belgium. The role leads a QA team, ensuring timely batch reviews, releases and compliance across GxP processes in a fast-paced environment.

Ideal candidates hold a Master’s degree in engineering or science and have supervisory experience, with strong English and Dutch communication and a focus on quality in a cross-functional setting.

Qualifications

• Master’s degree in engineering, science or equivalent; supervisory experience preferred.
• Fluency in English and Dutch; strong cross-functional communication.

Responsibilities

• Lead QA Cryo team and ensure CAR-T QA operations at Beerse center.
• Perform batch record reviews and releases.
• Collaborate with Cryo Operations, MES, IT, and QA Ghent to align priorities.
• Oversee GxP processes, deviations, audits and change controls.
• Provide clear direction and escalate risks as needed.

Skills

English proficiency

Dutch proficiency

People leadership

Communication

Problem solving

Education

Master’s degree in engineering or science

Tools

SAP

COMET

eLIMS

MS Office

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Beerse, Antwerp, Belgium

Job Description:

QA Cryo Supervisor CAR-T

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, andsolutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which works by harnessing the power of a patient’s own immune system. They are created from the patients’ own T-cells and are engineered to eliminate cancer cells expressing a specific antigen.

Johnson & Johnson is recruiting a QA Cryo Supervisor for its CAR-T Cryopreservation Center in Beerse, Belgium. Working closely with the QA Cryopreservation Manager, this role leads a team of QA Associates Cryo and is accountable for ensuring sustainable EMEA CAR-T Quality Assurance operations at the Beerse Cryopreservation Center.

Leadership Skills & Key Responsibilities:

Leads, coaches and develops a team of QA Associates Cryo to achieve quality, business and individual performance objectives.

Provides visible, day-to-day leadership with integrity, including setting priorities, conducting performance reviews, recognizing contributions, redirecting performance, addressing concerns and resolving conflict.

Partners with the QA Cryopreservation Manager to translate business and quality priorities into clear daily and weekly plans, safeguard Quality operational continuity and independently drive actions to completion.

Performs day-to-day QA activities, including timely batch record review and batch release, while balancing hands-on execution with team leadership responsibilities.

Serves as the primary point of contact for daily QA Cryo operations, providing clear direction, proactively resolving issues and removing barriers to ensure timely execution of daily activities.

Builds effective partnerships with key stakeholders, including Cryo Operations, MES, IT, EQ, QA Ghent, V2V and MSAT, to align priorities and facilitates clear, effective communication.

Aligns objectives and deliverables across Quality functions and with Quality Management to ensure one clear QA voice; communicates progress transparently and concisely and promptly escalates critical risks and issues.

Supports quality-focused meetings and Tiers, assigns and follows up actions, and helps monitor performance through relevant KPI’s.

Supports the oversight of GxP processes, including batch record reviews, deviation handling, change controls and other GxP documentation, ensuring compliant and timely execution.

Acts as a trusted subject-matter partner with clear operational oversight and supports the preparation and execution of internal and external audits.

Identifies improvement opportunities and engages the team in implementing pragmatic lean solutions that strengthen quality and sustainable performance.

Experience

Master’s degree in engineering, Science or an equivalent technical discipline, with experience in Quality Assurance

Prior experience in cell and gene therapy is preferred

Proficiency in written and spoken English and Dutch, with strong communication skills and confidence in cross-functional meetings.

Understands the interplay between QA operational reality, compliance and patient impact, and makes clear, informed decisions.

A prior supervisory experience is a preference

Empathy, integrity and authenticity are key for this role

Preferably has knowledge of Tissues and Cells Directive, GTP, legislation on human body material or SOHO.

Detailed knowledge and understanding of Good Documentation Practices (GDP) or Good Manufacturing Practices (GMP) to identify/remediate gaps in processes or systems is required

Organized, analytical, structured and solution-oriented, with a strong focus on people.

Works independently while fostering collaboration around shared goals.

Experience with batch record review, deviations, audits, validation, MES or Opstrakker is a strong asset.

Feels comfortable working with a fully digital process flow. Experience working with SAP, COMET or eLIMS is a plus. Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint) is required

Motivated to take ownership in a growing and evolving environment.

Candidates must be able to accommodate a shift schedule: EARLY-LATE shift; and support remote stand-by as required by clinical / commercial demand

At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time.

Required Skills:

Preferred Skills:

• Business Alignment
• Business Behavior
• Coaching
• Compliance Management
• Continuous Improvement
• Data Analysis
• Detail-Oriented
• Goal Attainment
• Human-Centered Design
• Internal Controls
• Issue Escalation
• Problem Solving
• Process Oriented
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Standards

The anticipated base pay range for this position is:

€60,000.00 - €96,255.00

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.