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Legend Biotech is seeking an Associate Director of Quality Project Management and Strategy as part of the Quality team based in Raritan, NJ. 

Role Overview

The Associate Director of Quality Project Management and Strategy role is an exempt level position with responsibilities for providing quality oversight over process improvement projects within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will oversee, lead and support quality activities for continuous improvement efforts, Quality site strategy initiatives, assist with budgeting and COGs reduction, and quality projects. 

Key Responsibilities  

• Support and lead continuous improvement projects.
  
• Managing people to support Quality improvement initiatives.
  
• Provide quality and compliance input for site CI and remediation efforts.
  
• Schedule and manage Quality tasks associated with process improvements.
  
• Act as liaison for quality in support of site improvement projects and strategies.
  
• Support and maintain site Quality metrics / Site Quality Cascade.
  
• Collaborates with functional departments to resolve issues.
  
• Support drafting of standard operating procedures, change controls and other documentation.
  
• 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.
  
• Provide guidance to other employees in the interpretation of quality issues and participate in the development of technical or scientific initiatives and activities.
  
• Drive continuous improvement.
  
• Have advanced computer skills to increase department's productivity, as well as broadening technical and scientific knowledge.
  
• Detailed knowledge of Quality and Compliance standards. 
• Key Relationships: Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Quality Control, and Operations Technical Support. Manage people to support project improvement in the Quality organization.

Requirements

• Education: A minimum of a Bachelor’s Degree in Science, Information Science or equivalent technical discipline is required.
• Experience: A minimum of 12-14 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. Lean Six Sigma Certification is a plus.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Advanced Therapy Manufacturing Practices(ATMPs).
• 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).
• Language Requirements: English
• Travel Requirements: Potentially up to 5%

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