OPERATIONAL EXCELLENCE CONSULTANT – Pharmaceutical Clinical Product Quality:

Responsibilities:

Consultant responsible for identification and implementation of business processes, tools, templates and training materials associated with IMP Quality systems, operations, key activities, and accomplishments.  Launch a new intranet Wiki site for IMP Quality department and customer groups to reference and access newly created materials.

  • Partner with the Investigational Medicinal Product (IMP) Quality to scope the business processes, tools, templates, and training materials applicable to the department.
  • Design, develop, and launch an intranet Wiki site to align and reflect the organization structure and materials associated with the daily operations of IMP quality.
  • Implement IMP quality department branding across materials and Wiki site for logical, intuitive, quick access.
  • Leverage Six Sigma methods for development of instructions, tools, process maps, roles/responsibilities, templates, etc.
  • Develop materials to support, supplement, and uphold quality and compliance requirements articulated in SOPs and approved GMP training materials.
  • Identify, measure, control and enhance core business processes to maintain compliance and improve business performance and patient safety.
  • Lead business critical business process improvements that can range from conducting voice of customer sessions, facilitate process workshops, implement process improvements, define and track process metrics, and adoption of business process maps and guidance documents.
  • Evaluate/revise standard operating procedures where applicable during project execution.
  • Consult with internal stakeholders to determine impact, ensure alignment, and identify best practices from 360 degrees.
  • Think out of the box, challenge legacy processes, and implement new processes to add value.
  • Activities and tasks:
    • Develop detailed project plan showing list of deliverables, tasks, timelines, and milestones
    • Gather and document business requirements and ensure that the technology solutions meet those needs
    • Routine project status updates
    • Prompt issue escalation and resolution – business and technical
    • Manage process documentation and retention
    • Identify and implement improvement opportunities and initiatives as needed
    • Provide tactical support as demanded by project

Requirements:

  • A minimum of 5 years related experience in pharmaceutical clinical product quality systems and processes
  • Business Process Management or Six Sigma/Operational Excellence experience
  • Experience re-engineering or creating new processes for nimble, innovative, compliant product quality management
  • Contribute subject matter expertise to the project to identify and facilitate quick resolution, head-off potential pitfalls, and elevate overall team functionality.
  • Compliance auditing experience helpful.
  • Strong written and verbal communication skills.  Experience developing or providing technical writing support for development of SOPs, business process documents, and online content development.
  • Technical writing and training experience a big plus

Inquiries and Resumes:  info@bulletproofdocs.com

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