Associate Director, Quality IT

Legend Biotech US • Somerset, NJ

10d • Hybrid

About The Position

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 an Associate Director, Quality IT as part of the Compliance team based in Somerset, NJ.
Role Overview
The Associate Director, Quality IT is responsible for leading the IT Quality team and providing IT Quality oversight for the implementation and lifecycle management of GxP IT systems within Legend Biotech. Duties include, but are not limited to interpreting applicable regulations, defining IT QA requirements and implementing processes and procedures at Legend that comply with regulatory guidelines and company standards. This position will ensure that GxP electronic systems(eSystems) adhere to both national and international regulatory guidelines on Electronic Records, Electronic Signatures, Data Integrity, cGMP, GCP, GLP, FDA 21 CFR Part 11/210/211, EU Annex 11, MHRA and GAMP5 guidelines.

Requirements

• A minimum of a Bachelor’s degree in Science, IT, Engineering or equivalent technical discipline. Advanced degree preferred.
• 12 years of relevant work experience within a pharmaceutical / biotech industry is required. A minimum 8 years of IT quality leadership experience is also required.
• Experience collaborating and communicating effectively with internal and external stakeholders.
• Proficiency in QMS software, document control, validation tools, change control systems, LIMS, ERP systems (SAP considered a plus).
• Ability to clearly represent compliance requirements and drive continuous improvement following risk-based approaches.
• Highly motivated, flexible, and excellent organizational skills.
• Experience working in Quality Assurance, Quality Systems and/or IT.
• Strong knowledge of global GxP regulations (US is a must; EU, China and GTP are considered a plus).
• Excellent verbal and written communication skills.
• Ability to prioritize and balance work from multiple projects in parallel.

Nice To Haves

• Advanced degree preferred.
• ERP systems (SAP considered a plus).
• Strong knowledge of global GxP regulations (US is a must; EU, China and GTP are considered a plus).
• Regulatory Agencies firsthand inspection experience considered a plus.
• Clinical and GLP audit experience considered a plus.

Responsibilities

• Ensure that GxP IT systems, processes and records adhere to Legend CSV and SDLC procedures, FDA, EMEA and other regulatory requirements.
• Provide IT Quality oversight for GxP eSystem enhancement and validation activities inclusive of documentation and change controls.
• Direct and manage the IT Quality Team activities in accordance with compliance and business priorities.
• Contribute to the development and enforcement of applicable standard operating procedures at Legend.
• Work with cross functional teams for eSystem upgrades, maintenance, and recommendations for purchasing software, working with the relevant departments to develop user requirements and ensuring regulatory compliance.
• Assist in the development and coordination of Software Validation Plans; Installation, Operational and Performance Qualification protocols and reports; System Risk Assessments, Standard Operating Procedures; and Requirements Traceability Matrices.
• Maintain master files, profiles and tables for multiple software applications and drive harmonization across systems.
• Review and approve IT systems change management documentation, authorizing system use upon verification that requirements are met.
• Monitor error reports and assure data integrity. Investigate and document application problems and recommend system and/or procedural changes.
• Develop, maintain and execute the annual IT supplier audit program.
• Ensure audit observations, deviations, CAPAs are communicated, tracked, and remediated, in compliance with internal policies and procedures as well as with all applicable regulatory requirements.
• Provide Quality oversight for SOPs governing use and validation of eSystems.
• Work cooperatively with members of interdepartmental eSystem committees to ensure seamless communication among eSystems.
• Identify and mitigate risks associated with GxP IT systems and processes, developing strategies to address compliance risks.
• Train IT personnel and key stakeholders on GxP requirements and standards for computerized systems.
• Ensure that staff are developed and knowledgeable of regulatory expectations.
• Support continuous improvement efforts through the monitoring of process performance and metrics.
• Assist with inspection readiness efforts and program implementation.
• Support GxP regulatory inspections as required.
• Support Legend’s regulatory program and monitor the regulatory landscape to stay informed of regulatory trends and developments.
• Support development and gathering of quality metrics for Legend’s Quality Management Review (QMR).
• Establish key stakeholder relationships with all Legend Leadership Team, Legend Functional Leads, Legend Project Management, Legend Quality and Legend IT.

Benefits

• Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one.
• We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays.
• Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance.
• We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level