QA Car-t Qualification Lead Emea

**Job Function**:
Supply Chain Engineering

**Job Sub**Function**:
Quality Engineering

**Job Category**:
Scientific/Technology

**All Job Posting Locations**:
Gent, East Flanders, Belgium

Johnson & Johnson Innovative Medicine is recruiting a CAR-T QA C&Q Lead Engineer for the CAR-T hub in Europe.

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 started up two CAR-T manufacturing centers in the Ghent area (Belgium). The QC laboratories are operated from the existing J&J Beerse site.

As the CAR-T Qualification lead, you will play a pivotal role in ensuring the qualification of critical systems, equipment, facilities and utilities used in CAR-T Manufacturing. You will lead a team of QA C&Q engineers and collaborate cross functionally with engineering, maintenance, validation, and operation teams to ensure all systems and processes meet global GMP and regulatory expectations.

**Responsibilities**:

- Lead a team of CAR-T QA Qualification Engineers and coordinate all QA Qualification activities related to qualification (IQ/OQ/PQ) of equipment, facilities and utilities.
- Review and approve qualification documents such as change controls, master documents, protocols, reports, rationales, SOP’s, URS, IA, & QSR’s and related GMP documentation such as calibration rationales, calibration master forms and completed calibration records, master data set-up, maintenance plans.
- Review and approval of data integrity deliverables such as system audit trail and user access reviews.
- Ensure that deviations related to equipment issues with possible impact on quality and/or compliance are evaluated, thoroughly investigated and that adequate corrective and/or preventive actions are defined and implemented
- Ensure risk assessments (e.g. FMEA,) are appropriately conducted and documented.
- Serve as QA representative during internal and external audits and regulatory inspections.
- Support the implementation and continuous improvement of SOP’s and work instructions related to qualification.
- Collaborate cross functionally with the MAM (make asset management) and E&PS (engineering and property services) department and provide QA guidance during equipment and process lifecycle management, including control of changes.
- Train and support team members and stakeholders in qualification and GMP compliance topics.
- Participates in system and process improvement/optimization projects and assure quality and compliance aspects and maintain a current knowledge of international regulations, guidelines and industry practices and become the QA process expert.
- Supports in defining qualification project schedules, keeps quality oversight of qualification activities and makes sure milestones are met in a compliant manner.
- Escalates to management in a timely manner, when required.
- master’s degree in engineering with chemistry or analytical background or in pharmaceutical sciences.
- At least 5 years of relevant QA or Qualification experience in a GMP regulated pharmaceutical or biotechnology environment.
- Deep understanding of cGMP regulations such as (EU GMP Annex 1, PART IV, ICH, 21 CFR Part 11).
- Strong communication skills in English (written and verbal).
- affinity with computerized systems, system parameter configurations and data management in critical production assets.
- Strong analytical thinking, risk assessment and communication skills.Collaboration and teaming skills.
- **What is in it for you?**

You will be part of an enthusiastic team that has a strong quality focus on technology, qualification, automation, and continuous improvement. Employees are very valuable to our organization and development is a daily responsibility. Through on the job training, e-learning, implementation of various projects and programs we ensure personal growth by focusing on your talents. We offer you a contract of indefinite duration with an attractive salary package including extra-legal benefits such as meal vouchers, additional pension plan and hospitalization insurance.

**Application Process