QA Cryo Supervisor CAR-T
PharmaBiotechMedTechQuality Assuranceheorgmpgdpemacroinformsap
Job description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: Quality Assurance Job Category: Professional All Job Posting Locations: Beerse, Antwerp, Belgium Job Description: QA Cryo Supervisor CAR-T At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com/. CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which works 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. Johnson & Johnson is recruiting a QA Cryo Supervisor for its CAR-T Cryopreservation Center in Beerse, Belgium. Working closely with the QA Cryopreservation Manager, this role leads a team of QA Associates Cryo and is accountable for ensuring sustainable EMEA CAR-T Quality Assurance operations at the Beerse Cryopreservation Center. Leadership Skills & Key Responsibilities: Leads, coaches and develops a team of QA Associates Cryo to achieve quality, business and individual performance objectives. Provides visible, day-to-day leadership with integrity, including setting priorities, conducting performance reviews, recognizing contributions, redirecting performance, addressing concerns and resolving conflict. Partners with the QA Cryopreservation Manager to translate business and quality priorities into clear daily and weekly plans, safeguard Quality operational continuity and independently drive actions to completion. Performs day-to-day QA activities, including timely batch record review and batch release, while balancing hands-on execution with team leadership responsibilities. Serves as the primary point of contact for daily QA Cryo operations, providing clear direction, proactively resolving issues and removing barriers to ensure timely execution of daily activities. Builds effective partnerships with key stakeholders, including Cryo Operations, MES, IT, EQ, QA Ghent, V2V and MSAT, to align priorities and facilitates clear, effective communication. Aligns objectives and deliverables across Quality functions and with Quality Management to ensure one clear QA voice; communicates progress transparently and concisely and promptly escalates critical risks and issues. Supports quality-focused meetings and Tiers, assigns and follows up actions, and helps monitor performance through relevant KPI’s. Supports the oversight of GxP processes, including batch record reviews, deviation handling, change controls and other GxP documentation, ensuring compliant and timely execution. Acts as a trusted subject-matter partner with clear operational oversight and supports the preparation and execution of internal and external audits. Identifies improvement opportunities and engages the team in implementing pragmatic lean solutions that strengthen quality and sustainable performance. Experience Master’s degree in engineering, Science or an equivalent technical discipline, with experience in Quality Assurance Prior experience in cell and gene therapy is preferred Proficiency in written and spoken English and Dutch, with strong communication skills and confidence in cross-functional meetings. Understands the interplay between QA operational reality, compliance and patient impact, and makes clear, informed decisions. A prior supervisory experience is a preference Empathy, integrity and authenticity are key for this role Preferably has knowledge of Tissues and Cells Directive, GTP, legislation on human body material or SOHO. Detailed knowledge and understanding of Good Documentation Practices (GDP) or Good Manufacturing Practices (GMP) to identify/remediate gaps in processes or systems is required Organized, analytical, structured and solution-oriented, with a strong focus on people. Works independently while fostering collaboration around shared goals. Experience with batch record review, deviations, audits, validation, MES or Opstrakker is a strong asset. Feels comfortable working with a fully digital process flow. Experience working with SAP, COMET or eLIMS is a plus. Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint) is required Motivated to take ownership in a growing and evolving environment. Candidates must be able to accommodate a shift schedule: EARLY-LATE shift; and support remote stand-by as required by clinical / commercial demand At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time. 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. Final steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these. Finally, at the end of the process, we’ll invite you to share feedback in a short survey — yo
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