Legend Biotech is seeking a Director of External Manufacturing Quality as part of the Quality team based in Somerset, NJ. 

Role Overview

The Director of External Manufacturing Quality will be responsible for overseeing external manufacturers in support of the Legend clinical pipeline for cell therapy drug substance and drug product manufacturing. This role will provide quality oversight and ensure external sites operate in full compliance with established cGMP clinical requirements.  This individual will be a key leader in the US Operations organization and a champion for quality principles and compliance. The role develops and implements long-term quality strategies for the transfer and execution of the Legend clinical products. This role will also manage a team of people leaders and technical professionals within the QA department based on assigned work, direction, coaching and developing capabilities. The Director will collaborate with cross-functional and external counterparts to develop and establish compliance requirements for external partners manufacturing Legend pipeline products. 

Key Responsibilities  

• Serves as the External Manufacturing Quality Lead in support of cell therapy pipeline manufacturing operations at Contract Manufacturing Organization (CMOs).
• Provide leadership and oversee the Quality functions (Quality Assurance, Quality Systems, Quality Control) of external CMOs.
• Assure the required processes, procedures, systems and resources are in place to ensure a compliant disposition of materials and cell therapy products.
• Collaborate with other leaders across the organization and assist in the continuous improvement and Product lifecycle management at the CMO.
• Provide guidance and direction for policies and quality management system for clinical phase manufacturing.
• Partners with other internal and external Quality Heads to ensure harmonization and alignment with Quality Policies, Guidelines, Programs and Systems.
• Establishes effective partnerships with other business units, sites, and individuals to ensure business processes are effectively linked.
• Establish a Quality Management Review program to review and analyze external quality metrics.
• Perform audits of CMOs as needed.
• Develop and negotiate Quality agreement with the CMOs.
• Liaison between Legend and the CMOs during any Health authority inspections of the CMO facilities.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Travel as needed to CMOs to support quality activities, up to 50%.
• Other duties will be assigned, as necessary.
• Works in a collaborative team setting with quality counterparts that include Technical Development, Analytical Development, Manufacturing Operations, Engineering and Maintenance, Supply Chain and Planning.

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.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).

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