Legend Biotech US is looking for an Associate Director, Quality IT to lead the IT Quality team and provide quality oversight for the implementation and lifecycle management of GxP IT systems. This position ensures these electronic systems adhere to regulatory guidelines and company standards.
What You'll Do
- Ensure 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, including 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.
- Work with cross-functional teams on eSystem upgrades, maintenance, software purchasing recommendations, user requirement development, and ensuring regulatory compliance.
- Assist in developing and coordinating 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 and authorize system use upon verification that requirements are met.
- Monitor error reports, assure data integrity, investigate and document application problems, and recommend system or procedural changes.
- Develop, maintain, and execute the annual IT supplier audit program.
- Ensure audit observations, deviations, and CAPAs are communicated, tracked, and remediated in compliance with internal policies and applicable regulations.
- Provide Quality oversight for SOPs governing use and validation of eSystems.
- Work cooperatively with interdepartmental eSystem committees to ensure seamless communication.
- 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 staff are developed and knowledgeable of regulatory expectations.
- Support continuous improvement efforts through monitoring 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 trends.
- 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.
What We're Looking For
- A minimum of a Bachelor’s degree in Science, IT, Engineering, or equivalent technical discipline.
- 12 years of relevant work experience within a pharmaceutical/biotech industry.
- A minimum of 8 years of IT quality leadership experience.
- Experience collaborating and communicating effectively with internal and external stakeholders.
- Proficiency in QMS software, document control, validation tools, change control systems, LIMS, and ERP systems.
- Ability to clearly represent compliance requirements and drive continuous improvement following risk-based approaches.
- Highly motivated, flexible, with excellent organizational skills.
- Experience working in Quality Assurance, Quality Systems, and/or IT.
- Strong knowledge of global GxP regulations (US is a must).
- Excellent verbal and written communication skills.
- Ability to prioritize and balance work from multiple projects in parallel.
Nice to Have
- Advanced degree preferred.
- SAP experience considered a plus.
- EU, China, and GTP regulatory knowledge considered a plus.
- Regulatory Agencies firsthand inspection experience considered a plus.
- Clinical and GLP audit experience considered a plus.
Technical Stack
- QMS software
- Document control systems
- Validation tools
- Change control systems
- LIMS
- ERP systems (SAP)
Team & Environment
This role is part of the Compliance team, leading the IT Quality team.
Work Mode
This is an onsite position located in Somerset, NJ.
Legend Biotech US is an equal opportunity employer.
