The Role
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 crossfunctional teams to translate complex processes into clear product requirements and maintain a wellstructured 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.
We need someone who can balance compliance with innovation while driving measurable value and user adoption.
Your responsibilities:
Define and communicate the product vision and roadmap aligned with pharma business goals and regulatory timelines for Planisware set of applications.
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 usercentric, compliant product enhancements.
Essential skills/knowledge/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+).
Handson 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 crossfunctional setup.
Ability to manage and prioritize a product backlog that balances business value, compliance needs, and technical constraints.
Strong analytical and problemsolving mindset, especially in regulated or highcomplexity environments.
Excellent communication skills for engaging both technical and nontechnical stakeholders.
Proven ability to operate in ambiguity, drive clarity, and make decisions in compliancedriven environments.
Desirable skills/knowledge/experience:
Familiarity with FAIR data principles, data governance frameworks, and digital transformation in life sciences.
Product management certifications such as CSPO, PSPO, or SAFe PO/PM.
Understanding of automation, AI/ML, data engineering, or modern cloud technologies.
Exposure to scaling Agile delivery in complex or regulated enterprise environments
