QA CAR-T Qualification Lead EMEA

Job Description:

Johnson & Johnson Innovative Medicines 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.

Job Responsibilities

The preferred candidate will:

• 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.
• Participate 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.
• Support in defining qualification project schedules, keeps quality oversight of qualification activities and makes sure milestones are met in a compliant manner.
• Escalate to management in a timely manner, when required.

The candidate should have to following proficiencies:

• 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.
• ability to show and apply strong communication skills and are known as a great teammate who can work cross departmental in a continuous changing environment.
• Strong analytical thinking, risk assessment and communication skills.
• Collaboration and teaming skills.

Preferred Skills:

Coaching, Consistency, Controls Compliance, Critical Thinking, Data Savvy, Engineering, Financial Competence, Good Automated Manufacturing Practice (GAMP), ISO 9001, Lean Supply Chain Management, Leverages Information, Process Improvements, Quality Control (QC), Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Technologically Savvy

Hybrid Work