Prothena

  • Director, Quality - Learning Management, Document Management

    Job Locations US-CA-South San Francisco
    Job ID
    2018-1264
    Category
    Research & Development
  • Overview

    This position will be responsible for leading strategy and implementation for company-wide GxP Learning and Development (processes, systems, governance of training curricula and reporting) and Document Management (processes, systems, templates, archiving, Quality Lead for document change processes, retention schedules).   

    Responsibilities

    • Develop vision and strategy for company-wide learning and development within the regulated functions (e.g., GMP, GCP, GLP, GDP) and develop strategic partnerships with additional learning management content owners (g., HR, Compliance, Commercial).
    • Lead the development, implementation, and management of company-wide learning and development processes, systems, curricula and reporting to ensure optimal performance and compliance with laws and regulations in all relevant territories.
    • Lead the development, implementation, and management of company-wide document management processes, systems, archiving and retention to ensure optimal performance and compliance with laws and regulations in all relevant territories.
    • Oversee Global Procedural Document Control.
    • Oversee development and design document templates for SOPs, TP, Specifications, Reports, and Protocols preferably in eCTD format.
    • Interact with all departments to develop functional documentation and training requirements and implement processes and systems as appropriate.
    • Participate as a member of the Quality Leadership team fostering a compliant, efficient, effective Quality Management System supporting Prothena product development and commercial objectives.
    • Represent training and document control functions and systems in health authority inspections and internal audits.
    • Build and lead a team of engaged quality professionals.

    Qualifications

    Education and Experience:

    • Bachelor’s degree in a scientific discipline, with advanced degree,
    • 10+ years of experience in the pharmaceutical industry; with 5+ years of experience directing Quality Management functions and staff including; leading document management, learning & development and recruiting, managing and developing high-performance
    • Experience managing electronic document management systems and learning management systems is required. Experience managing within electronic QMS and with computer system validation strongly desired.

    Competencies and Attributes:

    • Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Prothena’s culture and values – courageous, imaginative, selfless and joyful
    • Well-organized and detailed oriented professional, with strong verbal and written communication skills.
    • Good computer skills with experience and working knowledge of MS Office (Word and Excel, Access, Adobe Acrobat professional).
    • Strong collaboration skills with emphasis on Project Management and Process Excellence

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