Senior CSV Manager: GxP Systems & Cloud Validation

DeWinter Group; Redwood City (CA); Híbrido; USD 170.000 - 210.000; Jornada completa

Descripción de la vacante

DeWinter Group in Redwood City, CA seeks a Computer System Validation Manager to lead CSV initiatives for pharmaceutical and biotech systems in a hybrid work setting. You will partner with IS, QA, business owners, and vendors to plan and execute risk-based validation for new implementations and changes to GxP systems.

This role emphasizes data integrity, inspection readiness, and guidance on cloud-based SaaS validation, with opportunities to influence validation strategy, documentation, and

Formación

• Bachelor’s degree in Engineering, Life Sciences, Computer Science, or a related field.
• 10+ years of GxP computer system validation experience in pharmaceutical or biotechnology environments.
• Hands-on experience delivering validation projects.
• Strong knowledge of GxP requirements, 21 CFR Part 11, EU Annex 11, and GAMP 5.
• Experience authoring, reviewing, and assessing validation documentation (plans, URS, specs, test protocols, traceability matrices, summaries).
• Experience validating cloud-based SaaS systems and working with study-level electronic systems (EDC, IRT, PV).

Responsabilidades

• Lead CSV initiatives in a hybrid role, coordinating with IS Quality, QA, and business stakeholders.
• Plan and execute risk-based validation activities for new implementations and changes.
• Validate cloud-based SaaS platforms and assess vendor documentation within a risk-based strategy.
• Develop and strengthen CSV procedures, forms, and templates; ensure inspection readiness.
• Support data migrations, deviations, CAPAs, audits, and regulatory inspections.
• Guide multiple complex projects with minimal supervision and on-time delivery.

Conocimientos

GxP validation

21 CFR Part 11

EU Annex 11

GAMP 5

Risk-based CSV methods

Vendor coordination

Documentation & QA liaison

Cloud-based SaaS validation

Electronic records & signatures

Project leadership

Educación

Bachelor's degree in Engineering/Life Sciences/CS or related field

Herramientas

Veeva

Oracle Argus

TraceLink

Medidata

Trial Interactive

Descripción del empleo

DeWinter Group in Redwood City, CA seeks a Computer System Validation Manager to lead CSV initiatives for pharmaceutical and biotech systems in a hybrid work setting. You will partner with IS, QA, business owners, and vendors to plan and execute risk-based validation for new implementations and changes to GxP systems.

This role emphasizes data integrity, inspection readiness, and guidance on cloud-based SaaS validation, with opportunities to influence validation strategy, documentation, and