QA Investigations Associate CAR-T

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QA Investigations Associate CAR-T (Belgium)

Johnson & Johnson (J&J) is recruiting a QA Investigations Associate CAR-T (Belgium on site) for the CAR-T hub in Europe. The position will be based in Ghent Belgium.

CAR-T (chimeric antigen receptor T-cell therapy) is an innovative blood cancer treatment that uses the strength of the patients own immune system. The patients T-cells are genetically modified to eliminate the cancer cells. This advanced technology offers hopeful prospects to patients for whom other therapies provide no or insufficient results.

We are therefore working passionately on expanding our capacity for CAR-T treatments in Europe both at our existing site in Beerse (QC laboratories) and in Ghent where we have built two CAR-T manufacturing centers in the Ghent area (Belgium).

We are looking for strong talents who are eager to participate in this innovative and hopeful venture.

The QA Investigations Associate CAR-T CAR-T Europe is part of the QA investigational team and is responsible to ensure that product and process related investigations are properly handled on time and in line with all ATMP/GMP requirements.

Key Responsibilities:

• Deviation & CAPA Management: Investigate deviations non-conformances and implement corrective and preventive actions (CAPAs) to ensure process integrity and product quality
• CAPA Implementation: Identify and implement corrective and preventive actions (CAPAs) to address quality issues from investigations particularly those affecting product quality and patient safety
• Ensure that deviations with potential impact on patients and/or product supply are properly escalated.
• Ensure timely QA approval of GMP documentation and provide support in quality review meetings.
• Actively support continuous improvement initiatives and lean exercises.
• Audits & Inspections Support: Prepare for and participate in internal and external audits and inspections.
• Establish and maintain effective working relationships with the different business partners and Legend Biotech to ensure alignment of objectives and deliverables.

Qualifications

Education:

• You have a Masters Degree in a scientific or technical field (Engineering Bioscience Engineering Industrial Engineering Pharmacy Biochemistry ) with at least 3 years cross functional experience in the pharmaceutical industry.

Experience and Skills:

Required:

• Experience working in Quality Assurance.
• You work independently and successfully prioritizing and managing multiple tasks simultaneously.
• Your verbal and written communication skills enable you to proficiently negotiate and communicate with external and internal partners.
• Highly organized and capable of working in a team environment with a positive attitude under some supervision.

Preferred:

• Experience with aseptic processing and technics is preferred.
• Up-to-date knowledge and in-depth understanding of relevant pharmaceutical legislation related to clinical trials and cGMP regulations related to manufacturing of cell therapy products is an asset.

Other:

• You like to explore new paths to make full use of your knowledge and experience as well as to expand it so that new problems also get solutions.
• You see possibilities and you look for them even when they are not immediately clear.
• You like to work in a team towards a common goal.
• You consider diversity an asset.
• You can deal with procedures and guidelines that require strict application as well as situations where not everything is clear yet.

Our offer

• The opportunity to participate in a progressive treatment that gives hope to patients in need.
• Being able to help shape a new venture from the start.
• An innovative working environment.
• Training on the job for this specific treatment.
• Opportunities to continue to develop and grow in an extensive and strong organization.
• An open-ended contract and a competitive remuneration package.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness career and life journey please visit .

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.

Heres what you can expect:

• Application review: Well carefully review your CV to see how your skills and experience align with the role.
• Getting to know you: If theres a good match youll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.
• Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.
• Final steps: For successful candidates you will need to complete country-specific checks before starting your new role. We will help guide you through these.

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is:

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 locations 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.