Legend Biotech is seeking an Investigations Excellence Lead as part of the Quality team based in Raritan, NJ. 

Role Overview

The Investigations Excellence Lead manages the Quality Investigations program in support of cell therapy manufacturing, in full compliance with established cGMP requirements. Functions and activities include managing and leading activities focusing on Investigations and CAPAs, such as improvement projects and Kaizens, training qualification, coaching, and maintaining/reporting metrics and data. The role will be responsible for formal escalation of critical investigations and will develop and implement long-term strategies and continuous improvements for the Investigations program.

Key Responsibilities  

• Manage the quality activities for the cell therapy manufacturing investigations to ensure compliance with cGMP requirements.
• Partners with other functional investigations leaders to ensure harmonization and alignment with Procedures, Processes and Systems. 
• Lead and facilitate continuous improvement projects for the Investigations program.
• Responsible for the qualification and training program for Investigators and Quality Leads.
• Oversees coaching program for Manufacturing and QC Investigations.
• Monitor, trend and track Quality metrics for Investigations and CAPAs and other relevant quality systems.
• Responsible for leading escalation process for critical and OOS investigations.
• Manages team for Investigations within Quality.  Hires and develops employees within the department.
• Coordinates quality systems related activities among impacted individuals, departments, sites and companies as needed to proactively support business processes.
• Establishes effective partnerships with other business units, sites, and individuals to ensure business processes are effectively linked.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Other duties will be assigned, as necessary.

Requirements

• A minimum of a Bachelor’s Degree in Science, Information Science or equivalent technical discipline is required.
• A minimum of 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.
• 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.
• Proven people management and leadership experience is required.
• Experience working with quality systems is required.
• Extensive knowledge of chemical, biochemical and microbiological concepts is required.
• Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is preferred.
• 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.
• The candidate must be highly organized and capable of working in a team environment with a positive attitude.
• Good written and verbal communication skills are required.
• Ability to summarize and present results, and experience with team-based collaborations is a requirement.
• Experience developing and setting long-term objectives.
• 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.

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