We are seeking an experienced Product Owner with a strong background in pharmaceutical or other highly regulated industries to join a major Life Sciences programme in Stevenage.
This role sits at the intersection of digital innovation, compliance, and scientific workflows—requiring someone who can balance regulatory rigor with Agile product delivery.
The Role
You will define and drive the product vision, manage the backlog, and ensure that all product increments meet compliance standards including GxP, 21 CFR Part 11, Annex 11, and ALCOA+ principles.
Working closely with engineering, QA, scientific, manufacturing, and regulatory stakeholders, you will translate complex processes into clear, validated product requirements while ensuring audit readiness and validated deployment.
Key Responsibilities
* Define and communicate product vision and roadmap aligned to regulatory timelines
* Own and prioritise the product backlog
* Translate scientific/clinical/manufacturing workflows into user stories
* Lead Agile ceremonies (Sprint Planning, Refinement, Reviews)
* Collaborate across cross‑functional pharma stakeholders
* Monitor KPIs, adoption, compliance metrics, and drive continuous improvement
* Product Owner/BA experience within pharma, biotech, or regulated sectors
* Strong knowledge of GxP, 21 CFR Part 11, Annex 11, ALCOA+
* Hands‑on CSV/CSA and audit readiness exposure
* Agile (Scrum/Kanban) delivery experience
* Experience with regulated digital platforms (LIMS, ELN, MES, QMS, CTMS, Veeva desirable)
If you are passionate about delivering compliant digital products that accelerate scientific and healthcare outcomes, we would love to hear from you.
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