Sr. Manager Quality IT

About the role

The Sr Manager, Quality IT is responsible for providing IT Quality oversight for the implementation and lifecycle management of GxP IT systems within Legend Biotech. This position ensures that GxP electronic systems 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.

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 System enhancement and validation activities, including documentation and change controls.
• Contribute to the development and enforcement of applicable standard operating procedures at Legend.
• Work with cross-functional teams for system upgrades, maintenance, and recommendations for purchasing software, 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.
• Support and maintain the annual IT supplier audit program. Ensure audit observations, deviations, CAPAs are communicated, tracked, and remediated in compliance with internal policies and regulatory requirements.
• Provide Quality oversight for SOPs governing use and validation of IT Systems.
• 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.
• Support continuous improvement efforts through monitoring process performance and metrics.
• Assist with inspection readiness efforts and program implementation, and support GxP regulatory inspections as required.
• Support Legend’s regulatory program and monitor the regulatory landscape to stay informed of trends and developments.
• Support development and gathering of quality metrics for Legend’s Quality Management Review (QMR).
• Provide guidance to other employees in the interpretation of quality issues and participate in the development of technical or scientific initiatives.
• Establish key stakeholder relationships with Legend Leadership Team, Functional Leads, Project Management, Quality, and IT.

Requirements

• A minimum of a Bachelor’s degree in Science, IT, Engineering, or equivalent technical discipline. Advanced degree preferred.
• 10+ years of relevant work experience within a pharmaceutical, biotech, or medical device industry, with a minimum of 5 years of leadership experience.
• Experience collaborating and communicating effectively with internal and external stakeholders.
• Proficiency in QMS software, document control, validation tools, change control systems, LIMS, Veeva, and ERP systems (SAP considered a plus).
• 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.
• Regulatory agencies' firsthand inspection experience considered a plus.
• Clinical, GMP, and GLP audit experience considered a plus.

Skills

• Highly motivated, flexible, and excellent organizational skills.
• Experience working in Quality Assurance, Quality Systems, and/or IT.
• Ability to clearly represent compliance requirements and drive continuous improvement following risk-based approaches.
• Ability to quickly process complex information and make critical decisions with limited information and minimal oversight.

Benefits

• Medical, dental, and vision insurance.
• 401(k) retirement plan with a company match that vests fully on day one.
• Eight weeks of paid parental leave after three months of employment.
• Paid time off policy including vacation time, personal time, sick time, floating holidays, and eleven company holidays.
• 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.
• Voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs.

Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Pay

Pay Range (Base Pay): $127,313 - $167,099 USD

Schedule

This is a full-time, permanent position.