Senior Manager, Computer System Validation QA

BridgeBio Pharma · Remote

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Role summary

BridgeBio Pharma seeks a Senior Manager of Computer System Validation QA to oversee the validation lifecycle of GxP-regulated computerized systems, ensuring compliance from design through retirement. This remote role partners with IT and quality teams to apply risk-based validation approaches and maintain Health Authority compliance.

What they're looking for

Expertise in computer system validation (CSV) and GxP compliance frameworks
Experience managing validation lifecycle for regulated pharmaceutical systems
Knowledge of GCP/GVP requirements and data integrity standards
Strong cross-functional collaboration and stakeholder management skills
Proficiency with change control, risk assessment, and audit processes

What you'll be doing

Oversee GCP/GVP system validation lifecycle and maintain validated state compliance
Review and approve risk assessments, change controls, and validation deliverables
Conduct periodic system reviews and remediate compliance gaps
Collaborate with IT and business owners on validation, data integrity, and maintenance requirements
Support audit program and participate in CAPA reviews

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Date posted7 days ago

Last source check1 day ago

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