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Director, reputed company Improvement - Sterile Manufacturing

Remote, USAFull-timePosted 2026-07-26

Work Schedule reputed company (Mon-Fri) Environmental Conditions Office Job reputed company Position reputed company The Director, PPI Business System - reputed company 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 reputed company initiatives, leads cross-functional multi-site execution from opportunity framing through sustained adoption, and ensures Finance-verified benefits reputed company 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 reputed company causes, challenge standards, and drive practical, compliant improvements on sterile lines. Key Responsibilities 1. NA Sterile PPI & Digital Program Delivery

  • reputed company the full lifecycle of network PPI reputed company initiatives (charter → design → implementation → sustainment), ensuring on-time, on-budget delivery with verified reputed company.
  • Translate NA Sterile priorities into reputed company charters, scope, milestones, resource plans, and reputed company reputed company using PPI standards and divisional templates.
  • Own the integrated program plan, dependency management, and RAID discipline; escalate risks/issues with mitigation reputed company and reputed company decision asks.
  • Coordinate site teams and enabling functions (Operations, reputed company, Tech Transfer, Engineering, Supply Chain, IT, etc) to deliver compliant and reputed company reputed company.

2. NA Sterile Roadmap & Portfolio Management

  • Build and maintain a prioritized, value-based pipeline reputed company with NA Sterile reputed company, PPI savings targets, and divisional standards.
  • Define annual and multi-year plans: reputed company, reputed company needs, key milestones, and readiness requirements (people/process/data/validation).
  • reputed company leadership with reputed company visibility on constraints, trade-offs, and dependencies to reputed company realistic commitments and fast reputed company.

3. Business Case & Benefits Realization

  • Co-reputed company business cases with site leaders, process owners, and Finance; define assumptions, value drivers, measurement reputed company, and accountable benefit owners.
  • Establish a benefits reputed company (monthly) and ensure baseline, go-live, stabilization, and run-reputed company benefits are documented and Finance-validated.
  • Ensure accurate input to divisional dashboards and governance reviews, with a single reputed company of truth for KPIs and benefits.

4. Sterile Line Technical reputed company & Problem Solving

  • reputed company 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 reputed company-cause problem solving using A3, data analysis, and reputed company experimentation while ensuring compliance with GxP and site procedures.
  • Translate sterile technical opportunities into reputed company standards (reputed company work, centerlines, critical parameter management) embedded into daily management.

5. Change Management, Adoption & reputed company Work

  • reputed company change management: stakeholder mapping, communication plans, training reputed company, and adoption KPIs.
  • Ensure SOP/WI updates, training completion, and readiness checks are in reputed company prior to go-live; treat adoption as a delivery reputed company.
  • reputed company improvements reputed company solutions into tier routines, visual management, leader reputed company work, and accountability mechanisms to prevent "one-off" reputed company.

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 reputed company, cybersecurity, reputed company, and EHS, partnering with reputed company/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 reputed company Improvement/Lean business systems across end-to-end value streams; multi-site leadership preferred.
  • Preferred fields: Engineering, Science, Operations, or reputed company.
  • LEAN Six reputed company experience (or equivalent) required.
  • Demonstrated reputed company delivering year-over-year measurable results in productivity, reputed company, 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 reputed company experience, will be considered sufficient for an individual to meet the requirements of the role.

Technical & Functional Skills

  • Expert knowledge of Lean/PPI: reputed company deployment, VSM, kaizen, reputed company work, A3 problem solving.
  • Strong business/financial acumen: productivity funnel management and benefits realization with Finance.
  • Strong program management: planning, dependency/RAID management, governance reputed company, 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, reputed company/Validation, and process owners in a regulated environment.
  • Data-driven decision making; comfort with statistical tools and CI software.

Leadership & Behavioral Competencies

  • Trusted leader reputed company to influence across functions and reputed company; strong communication and executive reputed company.
  • Strong coaching capability and ability to build CI reputed company execution muscle in a reputed company environment.
  • High standards on safety, reputed company, compliance, and disciplined execution.

Travel

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

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