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IT QMS Project Manager
Division : Insulet Corporation
Location : Insulet Corporation, Billerica MA US 01821
Job Type : Full Time
Career Level : Manager (Manager/Supervisor of Staff)
Job Description :
Position overview:  Lead the Quality Management System implementation and support IT software validation efforts across the system landscape (QMS, ERP, Electronic Device History Record, interfaces, etc.).  Ensure best practice process redesign, improved system capabilities and easier access to information for the business.  Provide IT project planning, coordination and reporting.  Work collaboratively with business, IT staff and vendors.   Assist in defining and implementing enhancements and projects as needed.  Define and manage the IT portfolio for the Quality business function.  Provide end user support as required.
 
 
JOB / DUTIES / RESPONSIBILITIES
 
  • Lead the Quality Management system implementation for CAPA, Complaints, electronic device history record, Change Control, Document Mgt., Audit, Training and Regulatory Reporting etc.
  • Plan and manage projects including defining deliverables, work breakdown structures, effort estimates and project schedules.  Focus is on defining and delivering process improvements, system improvements and ensuring regulatory compliance.  
  • Lead business requirements and design efforts for QMS and related projects (ERP Approved Supplier List, Lot traceability etc.).  Oversee development and or integration efforts.  Conduct system configuration/setup
  • Identify process improvements and technology solutions to address business and technology gaps.  Conduct analysis to research and resolve business needs including business case development.  Develop Quality Systems strategy and annual project roadmap
  • Work closely with the business to define and develop systems validation plans and create validation deliverables, ensuring they met standards for FDA/CE audits. Manage the audit process including prep, coordination and finding resolution(s) 
  • Create project, risk mitigation, and communication plans, identify resource requirements, identify project costs, develop and conduct training and create other project deliverables
  • Lead testing efforts and define deployment and cutover plans.  Ensure successful go live(s).  
  • Manage the coordination of project activities with business owners/stakeholders and project team.  Communicate with all project stakeholders effectively as needed.
  • Provide end users support including diagnosis, testing, resolution and proactive communication to resolve system, integration and process related issues
  • Manage ongoing enhancements to the implemented solution complying with change control as well as maintaining the systems validated state
  • Act as primary liaison with the QMS system vendor on projects or resolving technical issues
 
JOB QUALIFICATIONS
 
Requirements
 
Knowledge / Education
 
Bachelor’s Degree or equivalent experience
PMP (desirable) or at least six years of IT project management experience
MBA or Master’s in Computer Science preferred
 
Job Experience
 
  • Minimum of 6 years experience in a GMP/FDA regulated environment (Med Device preferred)
  • Minimum 6 years of project management experience in implementing Quality System Applications or CFR applicable business solutions. (e.g. Master Control, Agile, Microsoft Dynamics AX, SAP, Trackwise etc); with at least three as the Project Manager
  • Experience working with cross-functional teams, remote teams and Contract Manufacturers
  • At least 4 years of  IT Software validation experience in a GMP environment
 
Skills/ Competencies
 
  • Action oriented self-starter who can drive complex projects with minimal guidance/oversight
  • Strong functional business knowledge including Quality (in depth) and Supply Chain (moderate)
  • Proven project management capability leading Quality systems implementations including meeting schedules, monitoring and resolving issues, achieving budget and managing change control processes
  • Proven ability to work in a fast paced environment with multiple teams, on concurrent projects
  • Exposure to defining and creating custom and ad hoc reports.  Understanding of data cubes and multi-dimensional reporting desirable
  • Understanding of ETL solutions and web services is a plus 
  • Extremely organized with excellent communication, influencing and negotiating skills.  Solid presentation and facilitations skills
  • Ability to review project deliverables for completeness, quality, and compliance with established project standards 
  • Solid experience with SDLC processes, GAMP5 and business analysis methodologies 

 

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