QA Investigations Supervisor

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 QA Investigations Supervisor as part of the Quality team based in Raritan, NJ.

Role Overview

The QA Investigation Supervisor will be a part of the Raritan Investigation Excellence Team. This individual will be responsible for guiding a team of QA Investigation Leads in support of NC/CAPA Investigation execution, Internal/external audit readiness/support, as well as supporting continuous improvement projects within the Raritan Investigations organization. The QA Investigation Supervisor is an exceptionally organized, logical professional who has the experience necessary to enhance the quality of our investigations, ensure compliance with applicable procedures, and ensure robustness of our Corrective and Preventative Action (CAPA) plans to the next level of accuracy, effectiveness, and compliance.

Key Responsibilities

Supervise QA Investigation Leads:

• Lead daily touch point meetings with their direct reports and monitor QA Investigation Lead workload.
• Provide guidance to quality leads in investigation performance, process knowledge of cell and gene therapy manufacturing, and compliance to ensure that investigations reviewed by the team adhere to a high standard of excellence.

Investigation Support:

• Responsible for ensuring that the investigation processes are compliant with all applicable regulatory requirements.
• Escalation of events that potentially represent significant quality issues or issues resulting in the delay of investigation closure and product release to management.
• Supporting the review of investigation execution related documents (SOP's, Work Instructions, Job Aides)
• Support QLs in the resolution of Roadblocks for investigations to ensure compliant closures in support of batch release and site timeliness goals.

Investigation Metrics Ownership:

• Ensure the health of the investigation process by owning and monitoring investigation metrics and implementing actions when metrics indicate a negative trend or failure to meet accepted criteria.

Internal/External Audit Readiness/Support:

• Serve as the Subject Matter Expert in preparation for and during both internal and external audits, including FDA, EMEA, etc.
• Ensuring a high level of competency and audit/inspection readiness of the overall Raritan investigation team. Coaching quality leads to audit readiness and preparing them and quality records for audits/inspections.

Continuous Improvement Project Support:

• Representing quality on the project improvement team, ensure process improvements are implemented incorporating quality risk management principles and that current effective reference documents supporting investigations are updated appropriately.

Requirements

• A minimum of a bachelor's degree in science or related field or equivalent experience required. Advanced degree preferred.
• A minimum of 5 years of Quality Assurance experience within a cGMP environment in the biotech/biopharma industry and Cell/Gene Therapy cGMP manufacturing experience preferred.
• A minimum of 2 years of experience managing a team.
• Significant experience utilizing training and quality tracking systems.
• Demonstrated experience in handling/leading complex multi-disciplinary investigations in a cGMP environment.
• Experience partnering with various levels of leadership across complex organizations.
• Ability to build strong partnerships and effectively integrate with Internal and external partners to drive projects/programs forward in a matrixed environment.
• Excellent organizational and project management skills with the ability to simplify and clearly communicate complex concepts.
• Strong analytical, problem solving, and decision-making skills.
• Excellent verbal, written, and presentation capabilities.
• Energetic and collaborative.
• Proficient in data collection and analysis
• Ability to critically review investigations to guide quality leads through the process of identifying and implementing improvements consistent with quality risk management principles.
• Must be capable of coaching and instructing others in analytical thinking.
• Must have the ability to develop and instruct both individuals and groups of individuals in a skill development environment.

#Li-RP1

#Li-Onsite

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.