QA Manager Car-t
il y a 1 jour
Johnson & Johnson (J&J) is recruiting a QA Manager 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 approach to eliminate cancer cells, which work 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.
To support the CAR-T program in EMEA, J&J build two CAR-T manufacturing centers in the Ghent area (Belgium). The QC laboratories are operating from the existing J&J Beerse site. CAR-T investigational medicinal and commercial CAR-T products are manufactured in the Ghent facilities.
In this role, you are reporting in the J&J QA CAR-T organization and work closely with your peers from Material Science and Technology, Operations and Quality Control.
The QA Manager, CAR-T Europe is responsible for the certification of CAR-T investigational medicinal and commercial CAR-T products manufactured in the Ghent facilities.
Major Responsibilities:
- Product Release & Certification: Act as a delegate of the Qualified Person (QP) for the release and certification of both investigational and commercial CAR-T products at the CAR-T facilities in Ghent.
- Investigation and Compliance Expertise: Provide technical, quality, and compliance expertise to support thorough investigations of deviations, complaints, and other quality issues to ensure timely and effective resolution.
- CAPA Implementation: Identify and implement corrective and preventive actions (CAPAs) to address quality issues from investigations, particularly those affecting product quality and patient safety.
- Inspection and Audit Support: Support the preparation, execution, and follow-up of internal and external audits and inspections, ensuring compliance with GMP and other regulatory standards.
- Quality Oversight and Documentation Approval: Contribute to quality oversight programs by reviewing and approving GMP documentation and actively participating in quality review meetings to support operational activities.
- Stakeholder Collaboration: Establish and maintain strong working relationships with internal teams, business partners, and external collaborators (e.g., Legend Biotech) to ensure alignment on quality objectives and deliverables.
- Continuous Quality Improvement: Lead initiatives that challenge existing processes and drive continuous improvements, fostering sustainable improvements in organizational and quality performance.
- Training and Coaching: Provide coaching and training to operational and QA associates to ensure understanding and adherence to quality standards and GMP requirements.
- Flexibility in Working Hours: The position may involve flexible working hours, depending on project demands or business requirements.
**Qualifications**:
Experience and Skills:
- Educational Background: A degree in Industrial Pharmacy, with at least 8 years of cross-functional experience in the pharmaceutical industry.
- Pharmaceutical Knowledge: In-depth understanding of pharmaceutical product development, qualification, packaging, validation, testing, release, and distribution processes.
- Regulatory Knowledge: Up-to-date knowledge of pharmaceutical legislation, including current Good Manufacturing Practices (cGMP) and Advanced Therapy Medicinal Products (ATMP) regulations.
- Analytical and Decision-making Skills: Strong analytical thinking and decision-making abilities, with a keen attention to detail.
- Communication Skills: Excellent verbal and written communication skills to effectively negotiate and interact with both external and internal customers and partners.
- Quality Systems Experience: Proven experience working with quality systems, ensuring compliance with industry standards and regulatory requirements.
- Aseptic Processing Knowledge: Experience with aseptic processing and techniques is required.
- Organizational Skills: Highly organized, capable of managing multiple tasks in a team environment, and able to work effectively under mínimal supervision while maintaining a positive attitude.
- Effective Communication: Strong written and verbal communication skills, with the ability to convey technical and regulatory information clearly.
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.
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