QA Release Weekend Car-t

**Job Function**:
Quality
**Job Sub Function**:
Quality Assurance
**Job Category**:
Professional
**All Job Posting Locations**:
Gent, East Flanders, Belgium

**QA Associate, CAR-T (weekend)**:
Johnson & Johnson (J&J) is recruiting a QA Associate 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 has 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 Operations and Quality Control.

The QA Associate, CAR-T (weekend) is responsible to take part in, and oversee the release activities which take place during the weekend shift, i.e. release of batches in line with all ATMP/GMP requirements whilst adhering to the established turn around timelines.

This position will involve working in a weekend shift (6AM - 6PM), on site.

**Major Responsibilities**:

- **Batch Documentation Review/Release**: Review and approve batch documentation to verify compliance with regulatory and company standards.

- **Quality Assurance Oversight**: Monitor and ensure adherence to Good Manufacturing Practices (GMP/ATMP) and other relevant quality standards during the manufacturing of CAR T-cell products. Provide guidance during the weekend in relation to the QA oversight on manufacturing and logistics processes.

- **Investigation Support and CAPA Management**: Provide technical, quality, and compliance expertise to support in-depth investigations related to deviations, complaints, and other quality issues to ensure timely resolution.

- **Inspection and Audit Support**: Assist in the preparation, execution, and follow-up of internal and external inspections and audits to ensure compliance with Good Manufacturing Practices (GMP) and other regulatory requirements.

- **Collaboration and Stakeholder Engagement**: Foster and maintain effective working relationships with internal teams, business partners, and external collaborators (e.g., Legend Biotech), ensuring alignment with quality objectives and deliverables**

**Flexibility in Working Hours**: This function requires working in a weekend regime, from 6 AM to 6 PM And this position may involve flexible working hours, depending on business requirements and/or hand-over needs.

**The initial training period will commence in dayshift during the week until training is complete.**

**Experience and Skills**:

- Educational Background: Certified Industrial Pharmacist with a Qualified Person accreditation is preferred. A degree in Pharmacy, with at least 3 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 preferred, with a solid understanding of the requirements for sterile manufacturing.

- 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.

**Here’s what you can expect**:

- **Application review**:We’ll carefully review your CV to see how your skills and experience align with the role.
- **Getting to know you**:If there’s a good match, you’ll 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.

**Required