Sr. Program Manager; Medical Devices

This position is ideal for senior-level program leaders with deep enterprise system deployment experience to join the Global Product Operations & Delivery organization as a Senior Program Manager, driving complex, multi-region transformation initiatives across Packaging & Labeling, Manufacturing, and Commercial operations.

Partnering with cross-functional global teams including IT, Manufacturing, Quality, Regulatory, Supply Chain, and Global Product Management, you will lead enterprise-scale system implementations that directly impact compliance, operational efficiency, and product delivery. This role is mission‑critical in enabling scalable, compliant, and digitally integrated operations across multiple manufacturing plants and global markets.

Lead end-to-end execution of large-scale enterprise system programs impacting multiple global sites (e.g., labeling systems, ERP integrations, MES integrations, PLM interfaces, content management platforms).

Own program governance, risk management, executive reporting, budget oversight, and cross-functional alignment.

Drive alignment between Packaging & Labeling, Manufacturing Sites, IT, Regulatory, and Quality to ensure compliant system rollout.

Oversee system validation strategy (CSV / CSA where applicable), change control integration, and plant-level implementation planning.

Establish integrated master schedules across business, IT, and plant work streams.

Lead executive steering committees with clear metrics, risk heatmaps, and milestone tracking.

Ensure regulatory and quality requirements (FDA, EU MDR, ISO 13485, GxP where applicable) are embedded into system deployment strategy.

Coordinate data migration, cutover strategy, hypercare support, and post-implementation stabilization.

Drive measurable business outcomes including cycle time reduction, cost savings, error reduction, and improved global standardization.

Education:

Bachelor’s degree required; advanced degree (MBA, MS Engineering, Operations, or related) preferred.

8-10+ years leading enterprise-scale, cross-functional system implementations in regulated industries (medical device, pharma, biotech, aerospace, etc.).

Demonstrated ownership of programs spanning multiple countries, manufacturing plants, and executive stakeholders.

Strong understanding of GxP, ISO 13485, FDA, EU MDR impacts to system deployment.

Proven ability to manage complex integrated master schedules, RAID logs, and governance frameworks.

Comfortable operating at Director/VP level with the ability to align senior stakeholders.

Ability to translate between IT architecture and operational business needs.

Experience leading programs through ambiguity, competing priorities, and enterprise change resistance.

Experience with SAP, MES, PLM (Arena), enterprise labeling systems, localization platforms, or enterprise content management tools.

Familiarity with system validation methodologies (CSV / CSA).

Executive-level presentation capability with concise storytelling and risk framing.

Lean / Six Sigma or operational excellence certification preferred.