About the Role
Product Owner
6 Month contract initially + Extensions
Based: Hybrid - 2-3 days onsite in Stevenage
Rate: £450 - £500 p/d - (via Umbrella company)
We have a great opportunity with a world leading organisation where you will be provided with all of the support and development to succeed. A progressive organisation where you can really make a difference. We have a great opportunity for a number of Product Owner's to join the team.
Key Responsibilities;
* Define and communicate the product vision and roadmap aligned with pharma business goals and regulatory timelines.
* Ensure all product capabilities meet relevant compliance standards, including GxP, ALCOA+, 21 CFR Part 11, and Annex 11.
* Own and prioritize the product backlog, balancing business value, scientific needs, regulatory requirements, and technical debt.
* Translate complex scientific, clinical, or manufacturing workflows into actionable user stories with clear acceptance criteria.
* Collaborate closely with engineering, data, QA, design, and business SMEs to deliver validated and compliant product increments.
* Lead Agile ceremonies such as sprint planning, refinement sessions, and sprint reviews.
* Ensure all deliverables meet validated-state requirements for deployment in regulated environments.
* Engage with stakeholders across scientific, clinical, manufacturing, regulatory, and quality teams to gather requirements and share product updates.
* Monitor product KPIs, user adoption, operational efficiency, and compliance metrics to guide continuous improvement.
* Uphold strong data governance and data integrity principles while driving user centric, compliant product enhancements.
Key Skills & experience:
* Proven experience as a Product Owner, Business Analyst, or similar role within pharmaceutical, life sciences, or other regulated industries.
* Strong understanding of GxP regulations, including 21 CFR Part 11, Annex 11, and data integrity principles (ALCOA+).
* Hands on experience supporting Computer System Validation (CSV) / Computer Software Assurance (CSA) processes, validation documentation, and audit readiness.
* Demonstrated ability to translate complex scientific, clinical, or manufacturing workflows into clear product requirements.
* Solid working knowledge of Agile methodologies (Scrum/Kanban) with experience leading Agile ceremonies.
* Experience collaborating with scientific, clinical, engineering, quality, or manufacturing teams in a cross functional setup.
* Ability to manage and prioritize a product backlog that balances business value, compliance needs, and technical constraints.
* Strong analytical and problem solving mindset, especially in regulated or high complexity environments.
* Excellent communication skills for engaging both technical and non technical stakeholders.
* Proven ability to operate in ambiguity, drive clarity, and make decisions in compliance driven environments
Tech Stack
product managementagile methodologiesscrumproduct backlog managementregulatory complianceGxP21 CFR Part 11Annex 11ALCOA+user story writingstakeholder engagement