Product Owner — Labeling Systems

Product Owner — Labeling Systems (Medical Device / Pharma)

Hands-on Product Owner contractor partnering with a Technical Product Owner to lead labeling system migrations and related activities.

Responsibilities

• Serve as the primary day-to-day point of contact for assigned labeling system migration projects.
• Lead requirements elicitation and facilitate stakeholder workshops with teams including Labeling, IT, Technical Quality, Regulatory Affairs (as needed), Manufacturing, and vendors.
• Convert requirements into user stories, acceptance criteria, and a prioritized backlog.
• Build and maintain migration roadmaps, release plans, cutover/rollout plans, and milestone tracking aligned to timelines.
• Coordinate cross-functional workstreams:
  • data mapping & migration
  • system integrations (ERP/PLM/LIMS where applicable)
  • testing and validation support
  • training and documentation updates
• Draft validation artifacts and test protocols (e.g., UAT test scripts / validation test cases) in partnership with Technical Quality, supporting IQ/OQ/PQ.
• Lead User Acceptance Testing (UAT): coordinate testers, capture results, triage defects, and prioritize remediation.
• Manage vendor coordination for configuration, data conversion, and testing deliverables.
• Maintain traceability between requirements, test cases, defects, and signoffs for regulatory/audit readiness.
• Provide regular status reporting, metrics, and readiness dashboards; help prepare go/no-go decision packs and support cutover, stabilization, and rollback plans.

Requirements

• 5+ years experience as a Product Owner, Business Analyst, or similar role delivering software implementations or system migrations.
• Strong backlog management, user story writing, acceptance criteria definition, and prioritization.
• Practical experience with data mapping and migration planning/execution.
• Proven ability to lead/coordinate UAT and acceptance activities.
• Strong stakeholder facilitation skills across technical and business groups.
• Familiarity with Agile/Scrum and SDLC.
• Strong written communication and documentation skills suitable for validation artifacts and audit evidence.
• Ability to work independently as a contractor while maintaining timelines.

Nice-to-Haves

• Familiarity with labeling systems / label management tools, PLM, ERP, or LIMS.
• Experience in regulated industries (medical device or pharmaceutical).
• Knowledge of software validation and regulatory expectations (e.g., traceability and validation artifacts).
• Certifications such as CSPO, PSM, CBAP, PMP, or equivalent.
• Experience working with external vendors and overseeing vendor deliverables.