Product Owner (Planisware/Life Sciences) - 12-Month Contract - Stevenage/London
Posted 1 day ago by Hamilton Barnes
£500 Per day
Inside
Hybrid
Stevenage, Hertfordshire, UK
Summary: Contracting role for a Product Owner specializing in Planisware applications within the pharmaceutical and life sciences sector, based in Stevenage or London. The position involves defining product vision and roadmap, ensuring compliance with regulatory standards, and translating complex workflows into actionable requirements. The role requires collaboration with various stakeholders and leading Agile ceremonies in a hybrid working environment.
Key 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
Key Skills:
- 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
Salary (Rate): £500 per day
City: Stevenage
Country: UK
Working Arrangements: hybrid
IR35 Status: inside IR35
Seniority Level: undetermined
Industry: Other
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