Product Owner (Planisware/Life Sciences) - 12-Month Contract - Stevenage/London
Contracting role based in Stevenage or London (Hybrid, 2-3 days in office) for a 12-month engagement within the pharmaceutical and life sciences sector. You will own the product vision and roadmap for a Planisware suite of applications, translating complex scientific, clinical, and manufacturing workflows into clear product requirements and ensuring all increments meet GxP, data integrity, and validation standards within a highly regulated environment.
Your responsibilities:
- Define and communicate the product vision and roadmap for the Planisware suite of applications, aligned to pharma business goals and regulatory timelines
- Own and prioritise the product backlog, balancing business value, scientific needs, regulatory requirements, and technical debt
- Ensure all product capabilities meet relevant compliance standards including GxP, ALCOA+, 21 CFR Part 11, and Annex 11
- Translate complex scientific, clinical, and manufacturing workflows into actionable user stories with clear acceptance criteria
- Collaborate with engineering, data, QA, design, and business SMEs to deliver validated and compliant product increments
- Ensure all deliverables meet validated-state requirements for deployment in regulated environments
- Lead Agile ceremonies including sprint planning, refinement sessions, and sprint reviews
- Engage stakeholders across scientific, clinical, manufacturing, regulatory, and quality teams to gather requirements and share product updates
Essential skills/knowledge/experience:
- Proven experience as a Product Owner, Business Analyst, or similar role within pharmaceutical, life sciences, or other regulated industries - essential
- Strong hands-on Planisware expertise to drive product roadmaps - essential
- Strong understanding of GxP regulations including 21 CFR Part 11, Annex 11, and ALCOA+ data integrity principles
- Hands-on experience supporting Computer System Validation (CSV)/Computer Software Assurance (CSA) processes, validation documentation, and audit readiness
- Solid working knowledge of Agile methodologies (Scrum/Kanban) with experience leading Agile ceremonies
- Strong analytical and problem-solving mindset in regulated or high-complexity environments
The Offer
- Day Rate: £500/day (inside IR35)
- Length: 12 months (Extenstion Potential)
- Mode: London/Stevenage Office (Hybrid)
- Start: ASAP