2025 · Certification
Certified SAFe® 6 Scrum Master
Scaled Agile Inc.
Freelance Specialist · Denmark · Available Now
Certified SAFe® 6 Scrum Master and IT Project Manager with 12+ years of consulting experience, 8 of which are focused on pharmaceutical life sciences — delivering GxP-compliant projects for the world's leading pharma companies.
About Me
I am an independent Scrum Master, IT/Technical Project Manager, and Compliance Specialist with over 12 years of IT consulting experience — the past 8 years focused exclusively on pharmaceutical and life science organisations.
My expertise spans GxP system implementation, SAFe agile frameworks at scale, risk-based validation, and intelligent automation. I've led cross-functional teams of up to 11 engineers and built a track record with global leaders including Novo Nordisk and Novartis.
As founder of Pharma Management Consulting, I am a business partner of Valenta and work closely with Managing Director Sven De Groodt to help life science organisations modernise their CSV testing and validation documentation through AI-powered automation on UiPath — maintaining full compliance with GAMP 5, FDA CSA, and EU GMP requirements.
Hands-on SAFe® 6 experience at team and program level — PI Planning, ART coordination, Kanban and Scrum at scale.
Deep knowledge of pharmaceutical regulatory frameworks, GAMP 5, FDA CSA, and EU GMP compliance across the full system lifecycle.
Fluent in English, Danish, and Icelandic — available for engagements across Scandinavia and Europe.
Education & Credentials
2025 · Certification
Scaled Agile Inc.
2012 – 2014 · M.Sc.
Technical University of Denmark (DTU)
2013 · Exchange Programme
Project Management · Finance · Innovation
2009 – 2011 · B.Sc.
University of Reykjavik, Iceland
2017 · Certification
Lean6sigma.eu
2021 · Certification
TraceLink Inc.
What I Offer
From agile transformation and programme delivery to serialization compliance and system validation — end-to-end project leadership across the pharmaceutical value chain.
Certified SAFe® Scrum Master with proven experience facilitating agile ceremonies at team and program level. I help pharmaceutical organisations adopt and scale agile while maintaining full GxP compliance.
Experienced in leading complex, cross-functional IT implementations across MES/OT, SCADA, RIMS, QMS, and laboratory systems — delivered on time, within scope, and in full regulatory compliance.
Deep expertise in pharmaceutical regulatory compliance across serialization, GxP validation, and quality management systems. I ensure your systems meet FDA, EU GMP, and GAMP 5 requirements.
Experienced Validation Lead across laboratory systems, QMS platforms, serialization solutions, and manufacturing execution systems. From validation strategy through to final reports and sign-off.
Track Record
A selection of key engagements from a career spanning global pharmaceutical leaders, innovative biotech, and technology consulting — each delivered under strict GxP requirements.
Scrum Master & Technical Project Manager · Digital, Data & IT – MI/OT Execution
Implemented and facilitated SAFe Scrum ceremonies at team and program level. Led development, testing, and GxP validation of SCADA and MES/OT gateway integration modules using Ignition and Line Optimizer. Optimised validation processes through a Risk-Based Validation (RBV) approach using Azure DevOps. Delivered global implementation of Siemens User Management Components (UMC).
Technical Project Manager · InterVIEW Alarm Management System Replacement
Led the full lifecycle of a complex legacy alarm management system replacement, including IT infrastructure relocation to a new SaaS platform. Managed analysis and implementation phases, stakeholder and vendor coordination, project planning, and GxP documentation development.
IT Project Manager · NextGen RIMS – Veeva Vault RIM Replacement
Led an 11-person cross-functional NNIT delivery team (quality, infrastructure, integrations, architecture) for Novo Nordisk's full RIMS replacement — migrating from Aris Global to Veeva Vault RIM. Supported the Agile Release Train, participated in PI planning, managed financials, resource allocation, and daily project operations using Azure DevOps.
Project Manager · Veeva Vault Clinical Suite – Global Implementation Programme
Contributed as Project Manager to the Design Phase for Veeva Vault Clinical Suite implementation. Drove key workstreams including Validation Plan & Strategy, Integration Plan & Strategy, Migration Plan, Change Management Plan, E2E Implementation Plan, and High-Level Cost Estimation.
IT Project Manager · System Manager · Compliance Consultant
Multi-client, multi-role engagement across Novo Nordisk, Orphazyme, Oncopeptides, Ascendis Pharma, Zealand Pharma, Elos Medtech, and Santen Pharmaceutical. Covered infrastructure cloud migration, TraceLink serialization implementations, GxP validation (V-model), system administration, and EMVO alert management.
IT Project Manager · Central Alarm Management System – Data Centre Relocation
Led the planning and execution of relocating physical servers hosting Novo Nordisk's Central Alarm Management System to a new virtual data centre in the Netherlands. Managed vendor coordination, stakeholder workshops, and end-to-end project delivery.
Trusted By
Delivering results for some of the most demanding and regulated organisations in the global pharmaceutical industry.
Novo Nordisk
Global Pharma
Novartis
Global Pharma
NNIT
Pharma IT Services
Ascendis Pharma
Biotech
Zealand Pharma
Biotech
Santen Pharmaceutical
Ophthalmology
Orphazyme
Rare Disease
Oncopeptides
Oncology
Elos Medtech
Medical Devices
Emerson Process Mgmt
Industrial Automation
Epista Life Science
CRO / Consulting
Your Company?
Let's find out ↗
Expertise
Let's Work Together
I'm available for freelance engagements across Denmark and Europe — ready to bring structure, momentum, and pharmaceutical expertise to your next programme.
jon@jonjonsson.com