Sr. Director, Global Quality Compliance

Legend Biotech is seeking Head of Compliance as part of the Global Quality team based in Raritan, NJ.

Role Overview
The Head of Compliance will be responsible for providing quality oversight over the compliance program within the global quality organization to ensure harmonization, alignment and execution of regulatory guidelines across all manufacturing areas, supporting both clinical and commercial sites. This individual will be a key leader in the Global Quality organization and a champion for quality principles and compliance. The role develops and implements long-term strategies and execution of Quality internal and external auditing programs across domestic, internal and external sites.

In addition, this role will support Compliance initiatives, such as inspection readiness, metrics implementation and review, overall regulatory compliance and implementation programs, and others as required. 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.

• Manage the global Compliance leads to ensure harmonization and alignment across all functions and sites.
• Support the development of the GMP Compliance program related to clinical/ commercial stage and manufacturing.
• Support Legend's regulatory program and monitor the regulatory landscape to stay informed of regulatory trends and developments.
• Assist with inspection readiness efforts and program implementation across all sites.
• Manage and support the implementation of the internal and external audit program.
• Schedule, execute, report and follow-up on internal and US and Global external audits (travel required).
• Ensure audit observations are communicated, tracked, and remediated in compliance with internal policies and procedures as well as with all applicable regulatory requirements.
• Support GxP regulatory inspections as required.
• Support the local Compliance and auditing teams for continuous improvement projects.
• Support the enhancement and Global harmonization of the supplier qualification program, including management of the electronic systems for this program.
• Work with External Quality and other internal functions to understand and mitigate any compliance risk and establish vendor quality scorecard.
• Support development and gathering of quality metrics for Legend's Quality Management Review (QMR).
• Support management of the Quality Management Review (QMR) program.
• Support continuous improvement efforts through the monitoring of audit metrics.
• Assist with the development, maintenance and execution of the annual audit programs.
• Works in a collaborative team setting with quality counterparts that include Quality Leads, site Compliance Leads, Manufacturing Operations, Technical Operations, Engineering and Maintenance, Supply Chain and Planning.

• 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.
• Extensive experience participating in regulatory inspections and internal audits.
• 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.
• Experience with collaborating and communicating effectively with service providers, suppliers, and CMO/CDMOs.
• 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 Power point).

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Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic…