Technical Product Owner - Labeling Systems (Medical Device / Pharma)

Role: Technical Product Owner — Labeling Systems (Medical Device / Pharma)

Duration: 18 months (contract)

Location: Remote or Hybrid (EST work hours expected), If in person: West Chester PA, Raynham, MA, or Palm Beach Gardens, FL?

Engagement: Contracted resource reporting to the Technical Product Owner (hiring manager)

Summary

We are seeking a hands-on Product Owner contractor to partner directly with the Technical Product Owner to lead labeling system migrations and related activities. This person will be the primary point of contact for assigned migrations, drive requirements and backlog work, coordinate cross-functional teams and vendors, and support validation activities by drafting test protocols and test artifacts in partnership with Technical Quality.

Key Responsibilities

Act as the direct point of contact for assigned labeling system migration projects and coordinate day-to-day execution with the Technical Product Owner.

Lead requirements elicitation and stakeholder workshops with Labeling, IT, Technical Quality, Regulatory Affairs (as needed), Manufacturing, and vendors.

Translate requirements into well-formed user stories, acceptance criteria, and a prioritized backlog.

Create and maintain migration roadmaps, release plans, cutover/rollout plans, and milestone tracking aligned to timelines.

Drive and coordinate cross-functional workstreams: data mapping & migration, system integrations (ERP/PLM/LIMS where applicable), testing, validation support, training, and documentation updates.

Draft test protocols (UAT test scripts, validation test cases) and validation artifacts; work closely with Technical Quality and the Technical Product Owner on IQ/OQ/PQ activities and audit-ready documentation.

Lead User Acceptance Testing (UAT), coordinate testers, capture results, triage defects, and prioritize remediation.

Manage vendor coordination and deliverables for configuration, data conversion, and testing.

Maintain traceability between requirements, test cases, defects, and signoffs for regulatory and audit readiness.

Provide regular status reporting, metrics, and readiness dashboards to the Technical Product Owner and stakeholders.

Help prepare go/no-go decision pack and support cutover, post-go-live stabilization, and rollback plans if needed.

Required Skills & Experience 5+ years 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 skills.

Practical experience with data mapping and migration planning/execution.

Proven ability to lead and coordinate UAT and acceptance activities.

Demonstrated stakeholder facilitation skills across technical and business audiences.

Familiarity with Agile/Scrum practices and SDLC.

Strong written communication and documentation skills suitable for validation artifacts and audit evidence.

Ability to work independently as a contractor and maintain timelines.

Desired / Nice-to-Have

Experience or familiarity with labeling systems, label management tools, PLM, ERP, or LIMS (useful but not required).

Experience in regulated industries (medical device or pharmaceutical).

Knowledge of software validation and regulatory expectations (e.g., traceability, validation artifacts).

Certifications: CSPO, PSM, CBAP, PMP, or equivalent.

Experience working with external vendors and drafting/overseeing vendor deliverables.

Primary Deliverables (examples)

Migration roadmap and detailed project plan with milestones and cutover dates.

Backlog of user stories with acceptance criteria and priorities.

Data migration mapping documents, conversion rules, and verification plans.

UAT test plans, test scripts, test execution records, and defect logs with resolution traceability.

Validation-related artifacts (test protocols drafted by contractor, executed with Technical Quality oversight).

Cutover/rollback plans and post-go-live support plan.

Training materials, release notes, and updated SOP references where applicable.

Weekly status reports and a migration dashboard (progress vs. plan, defects, readiness).\

Success Criteria / KPIs

Migration milestones met per agreed roadmap.

UAT pass rate and closure of critical defects prior to cutover.

Data migration accuracy and reconciliation metrics.

Stakeholder satisfaction and readiness for cutover.

Minimal production incidents in the defined post-go-live stabilization period.

Working Relationships / Stakeholders

Regular interactions with: Labeling, IT, Technical Quality, and potentially Manufacturing, Regulatory/RA, and external vendors.

Reports to and partners closely with the Technical Product Owner (hiring manager).

Notes on Validation Role

The contractor will aid in drafting test protocols, UAT scripts, and related validation artifacts but will execute these in partnership with Technical Quality and the Technical Product Owner. The contractor will ensure traceability, coordinate testers, and drive remediation of defects to meet validation/approval milestones.