Freelancer Detail | GMDP.Expert

GMDP-0079

Global LIMS Programme Manager | GxP Digital Transformation

Beschikbaar

Jaren ervaring

Quality Control

Specialisatie

Spanje

Locatie

Over deze expert

Senior programme manager with 15+ years leading GxP-regulated digital and data programmes in pharmaceutical, medical device and industrial environments across Europe, Asia and the Americas. Lead a global LIMS programme across 8+ manufacturing and QC laboratory sites: end-to-end master data migration, LIMS platform upgrades, instrument integrations and ERP (SAP S/4HANA) interfaces, with change control, CAB governance and compliance-aligned delivery. Background in Big Four consulting and global pharma transformation, with a track record of setting up PMO governance, rationalising scope and bringing complex multi-site programmes to go-live. Works in English, Spanish, French and Mandarin.

Competenties

Expert

Data Integrity Change Control

Gevorderd

Computer System Validation Computer system validation

Gemiddeld

CAPA Management Deviation Management Process validation Regulatory inspection support CAPA Management Deviation Management Medical devices & combination products

Certificeringen

Scrum Master & Agile Coach Master in Consultancy Lean Six Sigma / Kaizen / Global 8-D Specialist in International Management

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