Director, Continuous Improvement - Sterile Manufacturing

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.

• LEAN Six Sigma experience (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).

• In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

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.