QA Process Expert

Job content

About the job

We are seeking smart and ambitious QA Process Expert (Quality Person in Plant)for our Cell Therapy Manufacturing Legend Biotech site in Ghent

Company Introduction

From the very beginning, we’ve been focused on the science. We came together as a team of experts, committed to quality, driven by excellence, and dedicated to experimentation. Though we faced many challenges, we remained fearless in our research and rigorous in our thinking, pushing ourselves to work harder. But what impacted us the most was the enormous burden patients’ bear and the difficulties they face, which drove us to think about what’s next.

We believe it’s time to accelerate and expand that transformation. At Legend Biotech, we are excited to bring clinical trials to patients in our pursuit of a cure. While we are focused on CAR-T in multiple myeloma, we firmly believe the prospects of cellular therapy stretch beyond just one disease or indication. The spark of hope is lit. At Legend Biotech, we’re using that hope to ignite the future of CAR-T cell therapy.

Strategic Collaboration

Legend Biotech USA Inc. and Janssen Biotech, Inc., one of the pharmaceutical companies of Johnson & Johnson, have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR T platform and investigational treatment.

Role Overview:

The QA Process Expert is a position with responsibilities for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment.

Major Responsibilities:

• Serves as a Quality person in plant in support of cell therapy manufacturing.
• Collaborate with site personnel to provide guidance and determine resolution for manufacturing issues.
• Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints.
• Review and approve manufacturing procedures and batch records
• Real time review of all documentation and reporting in support of process unit operations and release activities.
• Ensure non-conformances are investigated thoroughly and approved in a timely manner and appropriate corrective and preventive action plans are implemented.
• Strive to reduce non-conformances in supported areas by proactively driving compliance.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Support regulatory inspections and audits by ensuring inspection readiness within facility.
• Perform internal housekeeping audits.

Qualifications:

Education:A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required or relevant years of experience within the pharmaceutical industry.

Experience:A minimum of 6 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. A minimum of 2 years of experience with quality support in clinical manufacture is preferred.

Capabilities, Knowledge, and skills:

• Aseptic processing in ISO 5 clean room and biosafety cabinets.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.
• Great attention to detail and ability to follow the procedures.
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
• Good written and verbal communication skills are required.
• Ability to summarize and present results, and experience with team-based collaborations is a must.
• Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk.
• Must exhibit strong leadership skills and effectively develop others.
• Ability to collaborate well with stakeholders, customers and peers.
• Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality.
• Must be able to discern the criticality of issues and to communicate to management regarding complex issues.
• Ability to manage conflict and issues that arise with internal or external customers.
• Fluency in Dutch and English

At some point in time the person will be required to accommodate shift schedule. Shifts include routine weekend and evening work as required by the manufacturing process.