Senior Quality IT Manager: GxP Compliance & Validation
Legend Biotech US
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Benefits offered by this job
Job summary
Legend Biotech is seeking a Sr Manager, Quality IT to oversee IT quality for GxP systems and lifecycle management in Bridgewater, NJ. You will interpret regulations, define QA requirements, and implement compliant processes across the Legend IT landscape.
Ideal candidates bring 10+ years in pharma/biotech with leadership, strong regulatory knowledge, and experience with QMS, validation, and ERP/SAP environments. Regulatory inspections and continuous improvement are core focus areas.
Qualifications
- Bachelor's degree in Science, IT, Engineering or equivalent technical discipline.
- 10+ years in pharma/biotech/medical device with leadership experience.
- Experience with QMS software, document control, validation tools, change control systems.
Responsibilities
- Provide IT Quality oversight for GxP IT systems and SDLC alignment.
- Develop and enforce SOPs and validation records.
- Coordinate audits, CAPAs and regulatory inspections as needed.
- Collaborate with cross-functional teams to ensure regulatory compliance.
Skills
Education
Tools
Job description
Legend Biotech is seeking a Sr Manager, Quality IT to oversee IT quality for GxP systems and lifecycle management in Bridgewater, NJ. You will interpret regulations, define QA requirements, and implement compliant processes across the Legend IT landscape.
Ideal candidates bring 10+ years in pharma/biotech with leadership, strong regulatory knowledge, and experience with QMS, validation, and ERP/SAP environments. Regulatory inspections and continuous improvement are core focus areas.
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