Product Owner

As a supplier to one of our pharmaceutical organisations, I am seeking for a Product Owner for a 12 months+ contract in London or Stevenage.

Responsibilities

We are looking for a seasoned Product Owner with strong experience in pharmaceutical or other highly regulated environments including Planisware skills. The candidate will be responsible for defining the product vision and roadmap for Planisware set of applications, ensuring alignment with business needs, scientific workflows, and compliance expectations. They must be able to work closely with cross functional teams to translate complex processes into clear product requirements and maintain a well-structured backlog. The role requires experience in Agile delivery, with accountability for ensuring that product increments meet GxP, data integrity, and validation standards. The individual should be comfortable collaborating with diverse stakeholders—scientific, technical, and quality teams—and communicating progress and risks effectively.

Experience

• Proven experience as a Product Owner, Business Analyst, or similar role within pharmaceutical, life sciences, or other regulated industries.
• Strong understanding and expertise in Planisware skills to drive roadmaps.
• 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.

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