QA Laboratory Compliance Manager

Legend Biotech is seeking a QA Laboratory Compliance Manager as part of the Quality team based in Raritan, NJ. 

Role Overview

The QA Laboratory Compliance Manager role is an exempt level position with responsibilities for providing quality oversight over the compliance program for the site Quality Control laboratories in support of both clinical and commercial manufacturing. This role will be responsible for managing Laboratory Quality Investigation Leaders, approving critical site Laboratory nonconformance investigations, and tracking of quality metrics. This role will also be responsible for the management of the QA Lab Oversight team and will oversee the reviewing and approving of site SOPs, method validation / qualification/ transfers, and general compliance / quality oversight for the laboratories. This role will have direct reports and will be responsible for managing the QA Laboratory Compliance team as well as the QA Lab oversight team.

Key Responsibilities  

• Manage teams providing quality and compliance oversight for the site laboratories for both clinical and commercial manufacturing
  
• Ability to manage multiple and complex projects, provide status reports and coordinate with other teams to complete projects in a timely manner
  
• Provide guidance to Quality Leaders about handling of various nonconformances and strategies for mitigation / remediation
  
• Perform timely escalations of potential significant quality issues to management
  
• Represent QA Lab Compliance and QA Lab Oversight in Site Escalation, MRB, and Tier meetings
  
• Collaborate with cross functional team (Investigation Management and Functional Area Owners) to align on root cause, corrections, and CPAs
  
• Provide insight and develop sound strategical approaches to complex investigations and associated CAPAs
  
• Collaborate with Batch Release team and communicate any roadblocks which may delay batch release and identify solutions to mitigate risk
  
• Manages cross-functional projects with many stakeholders
  
• Lead continuous improvement associated with laboratory investigation management
  
• Support regulatory inspections and audits by ensuring inspection readiness at all times
  
• Review and approve Method validation / qualification / transfer protocols and reports
  
• Support day to day activities and oversight for the laboratories to ensure quality, compliance, and adherence to global standards as well as regulatory requirements
  
• Review and approve change controls in relation to QA Laboratory Compliance
• Provide guidance to QALO and QA Laboratory Compliance teams as well as stakeholder teams in the interpretation of Quality Issues and participate in remediation and continuous improvement at the site
  
• 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 manager for decisions outside established processes.
  
• Routinely recognize and resolve quality issues or data trends. Seek management guidance on complex issues.
  
• Drive continuous improvement.
  
• Have advanced computer skills to increase department's productivity, as well as broadening technical and scientific knowledge.
• Key relationships: works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Engineering and Validation, Quality Control, Operations Technical Support, Supply Chain and Planning.

Requirements

• A minimum of a Bachelor’s Degree in Science, or equivalent technical discipline is required.
  
• 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, quality control, manufacturing compliance, clinical quality, or cell therapy.
  
• A minimum of 2 years experience managing direct reports
  
• Strong knowledge of Nonconformance and CAPA management process
  
• Strong management and interpersonal skills.
  
• Knowledge of cGMP/cGLP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceutical. Experience in supporting cell-based products as well as knowledge of Good Tissue Practices is a plus.
  
• Strong interpersonal and written/oral communication skills.
  
• Ability to quickly process complex information and often make critical decisions with limited information.
  
• 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 others in a team environment.
  
• Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP). Knowledge of current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing is a plus.
  
• Ability to identify/remediate gaps in processes or systems.
  
• Experience reviewing/auditing GMP documentation including but not limited to: SOPs, Work Instructions, Investigations, CAPAs, Change Controls
  
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).

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