Senior IT Quality Leader, GxP Systems & Compliance

BioSpace; Bridgewater (MA); Sur place; USD 127 000 - 167 000; Plein temps

Avantages offerts par ce poste

Medical, dental, vision insurance

401(k) with company match

Paid parental leave

Paid time off

Résumé du poste

Legend Biotech is a global biotechnology company focused on cell therapy, headquartered in Bridgewater, NJ. We seek a Sr Manager, Quality IT to oversee IT QA for GxP systems and ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP5, and global guidelines.

The role drives system validation, change control, SOP development, and risk assessments while coordinating with QA, IT, and regulatory teams to support inspections and ongoing compliance.

Qualifications

• Bachelor’s degree in Science, IT, Engineering or equivalent technical discipline.
• 10+ years in pharma/biotech/medical device with min 5 yrs leadership.
• Proficiency in QMS software, document control, validation tools, change control.

Responsabilités

• Provide IT QA oversight for GxP systems across SDLC and validation activities.
• Develop and enforce SOPs for IT quality and regulatory compliance.
• Coordinate with cross-functional teams for upgrades, changes, and vendor audits.
• Ensure data integrity and review IT systems change management documentation.
• Support inspections and regulatory readiness efforts.

Connaissances

QA knowledge

Regulatory experience

Leadership

Stakeholder management

Communication

Formation

Bachelor's degree in Science/Engineering/IT

Advanced degree preferred

Outils

QMS software

LIMS

Veeva

SAP (ERP)

Description du poste

Legend Biotech is a global biotechnology company focused on cell therapy, headquartered in Bridgewater, NJ. We seek a Sr Manager, Quality IT to oversee IT QA for GxP systems and ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP5, and global guidelines.

The role drives system validation, change control, SOP development, and risk assessments while coordinating with QA, IT, and regulatory teams to support inspections and ongoing compliance.