Data Integrity & Computerized Systems Validation Lead Europe
Core
Define and maintain Data Integrity (DI) and Computerized System Validation (CSV) frameworks to ensure compliance of GxP-relevant data and systems across European pharmaceutical packaging sites.
Role type
Lead, Data Integrity & Computerized Systems Validation
Builds
Validated computerized systems and compliant data management processes for pharmaceutical packaging
Domain
Pharmaceutical packaging / GxP regulated manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Data Integrity (DI) expertise, Computerized System Validation (CSV) expertise, GAMP5 knowledge, EU GMP Annex 11 knowledge, 21 CFR Part 11 knowledge, ALCOA++ principles, risk assessment, validation lifecycle management (URS, IQ/OQ/PQ), multi-site quality oversight, audit/inspection readiness, training strategy development, root cause analysis, CAPA implementation, MS Office proficiency
Preferred skills
Experience setting up and supervising CSV studies, experience with multi-site quality oversight
Technologies
GAMP5, EU GMP, Annex 11, Chapter 4, 21 CFR Part 11, ALCOA++
Responsibilities
Establish and maintain harmonized DI and CSV frameworks across Europe sites, Own DI and CSV policies and standards, Maintain oversight of DI and validation status of all GxP computerized systems, Lead and standardize DI and CSV risk assessments, Review and approve validation deliverables from a DI/CSV perspective, Act as SME during audits/inspections for DI and CSV, Drive inspection readiness and remediation of findings, Define and deliver training strategy for DI and CSV, Lead continuous improvement and harmonization initiatives, Lead and execute DI and CSV remediation activities, Develop and author DI and CSV deliverables including risk assessments and validation documentation
Seniority
Senior, hands-on IC with strategic oversight