Full Job Description
Legend Biotech is seeking QA Compliance/Quality Systems Specialist as part of Quality Operations team based in Raritan, NJ.
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.
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.
The QA Compliance/Quality Systems Specialist role is an exempt level position with responsibilities for supporting QA compliance activities within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will oversee and lead quality activities for risk management, continuous improvement efforts, annual product review and other quality system functions.
Lead site specific quality system continuous improvement activities resulting in compliance with enterprise standards and global procedures; Such as, site risk register process, global document gap assessments, adopting new or revised regulatory requirements, and good documentation practices.
Provide support and robust guidance for site risk management; review and approve site risk documents.
Lead and facilitate the creation of pFMEAs in support of process improvement projects.
Drive alignment and efficiencies between local and global processes through building positive relationships across functions, to meet unified business objectives and resulting in an effective quality system for the site.
Support risk management practices and applicable documentation during audits and inspections.
Design and deliver training for specific quality system topics, in both classroom setting and individual interactions.
Support the annual product review process.
Ensure and maintain a state of inspection readiness.
Support quality systems process related to CAPA, Change Control or Audit actions.
Manage cross-functional projects with many stakeholders.
Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
Require minimal direction to complete tasks, knows how to get resources and information from established internal contacts; consult with supervisor for decisions outside established processes.
Other duties will be assigned, as necessary.
Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Quality Control, and Operations Technical Support.
Minimum of a Bachelor’s Degree in Science, Information Science or equivalent technical discipline is required.
Minimum of 4 years relevant work experience is required. It is preferable that the candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.
Strong interpersonal and written/oral communication skills.
Ability to quickly process complex information and often make critical decisions with limited information.
Ability to handle multiple priorities on a daily basis while being flexible and responsive to frequently shifting priorities.
Proficient in applying process excellence tools and methodologies.
Ability to independently be responsible for a portfolio of ongoing projects.
Ability to pay attention to details and follow the procedures.
The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
Good written and verbal communication skills are required.
Ability to summarize and present results, and experience with team-based collaborations is a requirement.
Ability to work with and lead others in a team environment.
Experience developing and setting long-term objectives.
Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing.
Ability to identify/remediate gaps in processes or systems
Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred.
Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).