Case Study 02 · Global Pharmaceutical · Data Platform
A global R&D data platform under GxP governance
Delivering a global R&D data platform serving multi-site operations, with governance, testing and stakeholder alignment held to GxP standards.
The Situation
Research and development at the scale of a global pharmaceutical operates across sites, time zones and regulatory regimes. The data platform supporting it has to honour all of them.
The engagement called for product ownership of the platform itself, alongside the business analysis and governance to make it credible to R&D leadership and to the regulators standing behind them.
Approach
- Acted as Product Manager and Business Analyst across the platform, with accountability for prioritisation and delivery cadence.
- Led Agile delivery and stakeholder alignment across multi-site teams, keeping prioritisation transparent across geographies.
- Owned requirements, testing and governance under GxP — designed so audit-readiness was a by-product of delivery, not a separate workstream.
- Held the line between scientific stakeholders and engineering teams, translating in both directions.
Outcome
- Global data platform delivered supporting multi-site R&D operations.
- GxP governance embedded into delivery rhythm — audit posture maintained throughout.
- Stakeholder alignment held across geographies and disciplines, despite competing priorities.
What Travels
In regulated environments, the cheapest moment to design for compliance is before the first sprint. After that, every retrofit costs ten times what it should — and erodes the trust that makes the next release possible.
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