Director of Global Quality Assurance Validation

Director of Global Quality Assurance Validation

Somerset, New Jersey, United States

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 chimeric antigen receptor T‑cell, T‑cell receptor (TCR‑T), and natural killer (NK) cell‑based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting‑edge therapeutics for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Legend Biotech is seeking a Director of Global Quality Assurance Validation as part of the Quality team based in Somerset, NJ
.

The Director of Quality Assurance Validation role is an exempt level position with responsibilities for providing quality oversight over the validation and qualification activities for facility, equipment, systems, and processes within a cell therapy manufacturing plants to support both clinical and commercial requirements in a sterile GMP environment. This role will have oversight in the US and advise for EU for Quality Assurance Validation and will manage a team of people leaders and technical professionals within the QA department based on assigned work, direction, coaching and developing capabilities.

This role will collaborate with cross‑functional counterparts and manage QAV for Legend commercial and clinical sites.

• Manage team providing quality and compliance oversight for the qualification, validation, process and equipment and facilities maintenance activities within the manufacturing and testing plant.
• Ability to manage multiple and complex validation projects, provide status reports and coordinating with other departments or outside contractors/vendors to complete validation tasks.
• Provide insight and develop sound strategic approaches to complex investigations and associated CAPAs
• Provide leadership and build an exceptional team to manage the Quality Assurance Validation across multiple sites, 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, including providing guidance and direction for clinical phase GMP validation and operations.
• Partners with internal and external Quality Heads to ensure harmonization and alignment with Quality Policies, Guidelines, and Programs.
• 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.
• 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.

• 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,…