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

Role Overview

The Director of Quality Operations will lead the internal Legend cell therapy manufacturing facility at Somerset, NJ and ensure the site operates 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 and execution for the internal Legend clinical manufacturing facility. 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 counterparts to develop and establish early phase clinical operations for Legend.

Key Responsibilities  

• Serves as the Quality Lead in support of cell therapy pipeline manufacturing operations at Somerset, NJ
• Provide leadership and build an exceptional team to manage the Quality functions (Quality Assurance, Quality Systems, Quality Control), including hiring, mentoring and developing personnel.
• 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 for product life cycle strategy and management of GXP policies and quality management system, including providing guidance and direction for clinical phase GMP operations.
• Partners with other internal and external Quality Heads to ensure harmonization and alignment with Quality Policies, Guidelines, Programs and Systems.
• Analyzes regulatory authorities’ programs and activities in areas relevant to advanced therapy products and advises site and Quality management of potential and actual actions that could adversely affect the business, represent quality exposures, or represent opportunities to be pursued.
• 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.
• Establish and implement a Quality Management review process.
• Works in a collaborative team setting with quality counterparts that include Technical Development, Analytical Development, Manufacturing Operations, Engineering and Maintenance, Supply Chain and Planning.
• 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.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).

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