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Program Manager Jobs in Indiana

Program Manager

Tellus Solutions

  • Batesville, IN
  • 11 days ago

    Highlights

    Partner with Quality and Regulatory leaders to align PDE practices, quality system requirements, local procedures, and working-level execution before piloting or deploying changes. Engages cross-functional partners in Operations, Manufacturing, Supply Chain, Marketing, Medical, Service, Information Technology, Data Privacy, and other functions whose processes affect product development.

    Numbers & Facts

    LocationBatesville, IN

    Description

    Job Description:
    Required Skills
    • Regulatory & Quality Knowledge
    • Deep knowledge of medical device or other regulated product development
    • Design controls
    • Change control
    • Design history documentation
    • Quality system requirements
    • Working knowledge of FDA Quality System requirements and ISO 13485
    • Process Improvement
    • Demonstrated success leading end-to-end process improvement across multiple functions, sites, or business units
    • Expertise in Lean, Six Sigma, value-stream mapping, or equivalent process optimization methods
    • Record of delivering measurable results
    • Experience leading complex, cross-functional transformation or continuous-improvement initiatives in a matrixed organization
    • Practical experience applying automation and AI to business or technical workflows
    • Preferably in a regulated environment
    • Ability to translate complex regulatory and process requirements into clear, efficient, and usable ways of working
    • Strong facilitation, change leadership, and stakeholder-management skills
    • Ability to influence senior leaders and subject-matter experts
    • Demonstrated ability to establish metrics, analyze process performance, prioritize opportunities, and communicate recommendations to leadership
    • Excellent written and verbal communication skills
    • Credible with engineers, quality professionals, regulatory partners, and auditors
    • High degree of independence
    • Accountability for results in an ambiguous, cross-functional environment
    • Commitment to Baxter's mission, patient safety, quality, and leadership expectations
    • Assess and map end-to-end PDE, QMS, and related business processes that affect R&D
    • Work with executing teams to establish current-state cycle time, effort, handoffs, rework, and pain points
    • Develop and maintain a prioritized process simplification roadmap based on business value, compliance risk, effort removed, cycle-time reduction, and stakeholder readiness
    • Redesign high-priority processes to eliminate unnecessary steps, redundant activities, duplicate documentation, and unclear handoffs
    • Preserve patient safety, product quality, and regulatory compliance
    • Partner with Quality and Regulatory leaders to align PDE practices, quality system requirements, local procedures, and working-level execution before piloting or deploying changes
    • Clarify functional ownership, decision rights, phase criteria, roles, and interfaces across shared product development processes
    • Identify, prioritize, and implement practical AI and automation use cases for document drafting, review, search, data preparation, traceability, and knowledge retrieval
    • Establish appropriate governance, human review, documentation, and controls for AI-enabled processes in regulated environments
    • Lead pilots, measure before-and-after performance, capture lessons learned, and refine solutions prior to broader deployment
    • Develop updated procedures, job aids, reusable patterns, and training materials
    • Enable process owners and teams to sustain improvements after the engagement
    • Provide clear recommendations, progress updates, risks, and decisions to R&D PMO leadership and cross-functional stakeholders
    • Lead change through influence, facilitate alignment across functions, and resolve competing priorities without direct authority
    • First 90 days: Complete a current-state map of priority PDE and QMS flows
    • First 90 days: Quantify the most significant friction points
    • First 90 days: Align stakeholders on a prioritized simplification and AI opportunity roadmap
    • Months 4–9: Redesign and pilot two to three processes end to end
    • Months 4–9: Deploy selected AI use cases with governance in place
    • Months 4–9: Release updated procedures, tools, and training
    • Months 10–12: Demonstrate measurable reductions in development cycle time, process effort, or rework
    • Months 10–12: Document adoption and control effectiveness
    • Months 10–12: Transition ownership with a sustaining plan
    • Core measures: Cycle time, effort removed, rework reduction, adoption, process compliance, user feedback, and sustainability of results
    • Reports to CCS R&D PMO leadership
    • Works directly with R&D, PDE, Quality, and Regulatory process owners
    • Engages cross-functional partners in Operations, Manufacturing, Supply Chain, Marketing, Medical, Service, Information Technology, Data Privacy, and other functions whose processes affect product development
    Required Education
    • Bachelor's degree in engineering, science, quality, operations, business, or a related field — required
    Preferred Education
    • Advanced degree 
    Required Experience
    • Typically, 15 or more years of experience in product development, quality systems, operational excellence, process engineering, program management, or a related discipline
    • Significant experience in the medical products industry
    • Experience with validated systems, regulated digital tools, data governance, or AI governance 

    Preferred Certification
    • Lean Six Sigma certification or equivalent demonstrated mastery 

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