Director, Digital and Business Excellence North America Sterile

Work Schedule

Environmental Conditions

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 Bachelors 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.