Director, Digital Quality GMP Computer Oversight
Core
Develop and oversee risk-based validation and assurance strategies for GxP computerized systems to ensure patient safety, product quality, and regulatory compliance.
Role type
Director, Digital Quality GMP Computer Oversight
Builds
Validated enterprise and site-based GxP computerized systems, including SaaS, cloud, and AI solutions
Domain
Life sciences / Pharmaceutical / Computer System Validation (CSV)
Required skills
Risk-based validation planning, GxP lifecycle execution, Data integrity controls, Supplier quality assessment, Change control management, Audit readiness, Cross-functional leadership, Technical writing
Preferred skills
Advanced degree in life sciences or engineering, Professional certifications in Quality or CSV, Experience with SaaS/cloud/AI validation, Agile delivery models, Global deployment support
Technologies
SaaS, Cloud infrastructure, Low-code platforms, Robotic Process Automation (RPA), Advanced Analytics, AI solutions
Responsibilities
Develop risk-based validation plans and acceptance criteria for GxP systems; Lead or approve GxP assessments, test strategies, and release decisions; Oversee lifecycle maintenance including changes, upgrades, and system retirement; Assess data integrity controls and audit trails; Lead supplier assessments and define assurance expectations in contracts; Provide independent Quality review and support regulatory inspections; Coach validation specialists and lead cross-functional workstreams.
Seniority
Director, strategic leadership & hands-on oversight