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Product Owner
Posted 18 hours 24 minutes ago by Onyx-Conseil
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 prioritise 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.
- 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 prioritise 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.
This is an excellent opportunity on a great project of work. If you are looking for your next exciting opportunity, apply now and send your CV to me directly; we will respond as soon as possible.
We welcome applications from all sections of the community and from people with diverse experience and backgrounds.
Onyx-Conseil
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