Director, Digital Transformation & Continuous Improvement - Sterile Manufacturing

🌍 Remote, USA 🎯 Full-time 🕐 Posted Recently

Job Description

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.

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.
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.
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.
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.
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.
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.
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).
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.
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.
Ability to travel up to 50% across the NA Sterile network.