Sr. Specialist, Quality IT

The role

The Sr. Specialist, Quality IT provides IT Quality oversight and hands-on support for the implementation, validation, operation, and lifecycle management of GxP computerized systems. This role ensures compliance with regulatory requirements and company procedures for electronic records and data integrity.

What you will do

• Ensure GxP IT systems, processes, and records comply with Legend CSV/CSA and SDLC procedures.
• Provide IT Quality review and oversight for GxP system implementations, enhancements, and upgrades.
• Review validation and lifecycle documents including risk assessments, test protocols, and reports.
• Partner with IT, business, Validation, and Quality teams to support system maintenance and issue resolution.
• Support the development, revision, and implementation of SOPs and standards.
• Assess and document risks associated with GxP computerized systems and processes.
• Support investigations of system issues, deviations, and data-integrity concerns.
• Track assigned audit observations, deviations, CAPAs, and remediation actions.
• Support IT supplier qualification and annual supplier audit programs.
• Provide Quality oversight for system periodic reviews and lifecycle controls.

Required qualifications

• Bachelor’s degree in Science, Information Technology, Engineering, or an equivalent technical discipline.
• Minimum of 7 years of relevant experience in the pharmaceutical, biotechnology, or medical-device industry.
• At least 4 years supporting Quality Assurance, computerized system validation/assurance, IT Quality, or regulated computerized-system lifecycle activities.
• Working knowledge of global GxP requirements for computerized systems, including FDA 21 CFR Part 11, EU Annex 11, data integrity, and GAMP 5.
• Experience reviewing or authoring validation and lifecycle deliverables.
• Experience with one or more enterprise or regulated platforms, such as QMS, document management, validation management, change control, LIMS, Veeva, ERP, or SAP.
• Ability to apply risk-based CSV/CSA principles.
• Strong technical writing, documentation-review, analytical, and problem-solving skills.
• Ability to communicate clearly and collaborate effectively with internal stakeholders and external suppliers.
• Ability to prioritize and manage multiple concurrent assignments.

Nice to have

• An advanced degree or relevant professional certification
• Experience supporting audits or regulatory inspections
• Experience with clinical systems

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 including vacation, personal, sick, 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
• 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

Before you apply

• Applicants must be authorized to work in the United States.
• Employment eligibility will be verified through E-Verify.

About the company

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, the company advances the next generation of cell therapy.