Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Position Summary
The Director, PPI Business System - North America Sterile is accountable for end-to-end deployment and execution of the PPI business system across the NA Sterile network (GVL core, with scope expansion to RDG and PLN), delivering measurable improvements in throughput, OEE, right-first-time, deviation reduction, cycle time, service level, and COGS. The role translates operational and compliance challenges into a prioritized portfolio of PPI and digital initiatives, leads cross-functional multi-site execution from opportunity framing through sustained adoption, and ensures Finance-verified benefits aligned with site AOPs and NA Sterile savings targets.
Given the complexity of sterile manufacturing, this role requires deep technical understanding of sterile fill-finish operations to identify root causes, challenge standards, and drive practical, compliant improvements on sterile lines.
Key Responsibilities
1. NA Sterile PPI & Digital Program Delivery
• Lead the full lifecycle of network PPI and digital initiatives (charter → design → implementation → sustainment), ensuring on-time, on-budget delivery with verified impact.
• Translate NA Sterile priorities into clear charters, scope, milestones, resource plans, and success criteria using PPI standards and divisional templates.
• Own the integrated program plan, dependency management, and RAID discipline; escalate risks/issues with mitigation options and clear decision asks.
• Coordinate site teams and enabling functions (Operations, Quality, Tech Transfer, Engineering, Supply Chain, IT, etc) to deliver compliant and scalable outcomes.
2. NA Sterile Roadmap & Portfolio Management
• Build and maintain a prioritized, value-based pipeline aligned with NA Sterile strategy, PPI savings targets, and divisional standards.
• Define annual and multi-year plans: sequencing, capacity needs, key milestones, and readiness requirements (people/process/data/validation).
• Provide leadership with clear visibility on constraints, trade-offs, and dependencies to enable realistic commitments and fast decisions.
3. Business Case & Benefits Realization
• Co-develop business cases with site leaders, process owners, and Finance; define assumptions, value drivers, measurement methods, and accountable benefit owners.
• Establish a benefits cadence (monthly) and ensure baseline, go-live, stabilization, and run-rate benefits are documented and Finance-validated.
• Ensure accurate input to divisional dashboards and governance reviews, with a single source of truth for KPIs and benefits.
4. Sterile Line Technical Excellence & Problem Solving
• Provide hands-on technical leadership to identify and remove constraints on sterile lines (e.g., line performance losses, aseptic interventions, contamination risks, batch release delays).
• Drive root-cause problem solving using A3, data analysis, and structured experimentation while ensuring compliance with GxP and site procedures.
• Translate sterile technical opportunities into scalable standards (standard work, centerlines, critical parameter management) embedded into daily management.
5. Change Management, Adoption & Standard Work
• Lead change management: stakeholder mapping, communication plans, training strategy, and adoption KPIs.
• Ensure SOP/WI updates, training completion, and readiness checks are in place prior to go-live; treat adoption as a delivery milestone.
• Embed improvements and digital solutions into tier routines, visual management, leader standard work, and accountability mechanisms to prevent "one-off" gains.
6. Governance, Compliance, Data & Standards
• Apply the DPD PPI & Digital governance model, delivery gates, and documentation standards, ensuring audit readiness.
• Ensure compliance with GxP, data integrity, cybersecurity, privacy, and EHS, partnering with Quality/Validation and Cybersecurity to define and execute required validation activities.
• Confirm data readiness and KPI definitions, partnering with IT/OT and Data & Analytics to maintain consistent definitions and basic governance controls.
Qualifications & Requirements
Education & Experience
• Advanced degree + 6 years, or Bachelor's + 8 years leading Continuous Improvement/Lean business systems across end-to-end value streams; multi-site leadership preferred.
• Preferred fields: Engineering, Science, Operations, or related.
• Six Sigma Black Belt (or equivalent) required.
• Demonstrated success delivering year-over-year measurable results in productivity, quality, and cost in regulated manufacturing.
• Strong sterile manufacturing domain expertise required (aseptic fill-finish operations, sterile processing, contamination control, line performance drivers, deviation/CAPA, change control, batch release constraints).
Technical & Functional Skills
• Expert knowledge of Lean/PPI: strategy deployment, VSM, kaizen, standard work, A3 problem solving.
• Strong business/financial acumen: productivity funnel management and benefits realization with Finance.
• Strong program management: planning, dependency/RAID management, governance cadence, and stakeholder alignment.
• Digital enablement leadership is a plus: ability to build a prioritized digital pipeline and partner effectively with IT/OT, data engineering/analytics teams, Quality/Validation, and process owners in a regulated environment.
• Data-driven decision making; comfort with statistical tools and CI software.
Leadership & Behavioral Competencies
• Trusted leader able to influence across functions and levels; strong communication and executive presence.
• Strong coaching capability and ability to build CI and digital execution muscle in a matrix environment.
• High standards on safety, quality, compliance, and disciplined execution.
Travel
• Ability to travel up to 50% across the NA Sterile network.