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Job Function:
Quality
Job Sub Function:
Quality Assurance
Job Category:
Professional
All Job Posting Locations:
Gent, East Flanders, Belgium
Job Description:
Johnson & Johnson (J&J) is recruiting a QA Release Weekend Lead, with a Qualified Person accreditation, 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 Release Weekend Lead, CAR-T 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. Additionally, the function contributes to appropriate communication and hand-overs between the different work regimes (week and weekend shift).
This position will involve working in a weekend shift (6AM - 6PM) on site. This lead position will rotate between the locations in the Ghent facilities.
You will be responsible for:
* 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 products. Provide QA oversight and guidance for 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, ensuring alignment with quality objectives and deliverables.
* Training and Coaching: Provide coaching and training to associates to ensure understanding and adherence to quality standards and GMP requirements
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.
Qualifications/Requirements:
* Educational Background: Certified Industrial Pharmacist with a EU Qualified Person accreditation is required.
* A degree in Pharmacy, with at least 5 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 minimal supervision while maintaining a positive attitude.
* Effective Communication: Strong written and verbal communication skills, with the ability to convey technical and regulatory information clearly.
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
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Required Skills:
Preferred Skills:
Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Human-Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)