Director, reputed company Improvement - Sterile Manufacturing
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 reputed company, 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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