Global Senior Manager, Procedural Document & Training Quality Lead

Posted 1 year ago

Key responsibilities:

Procedural Document Management

  • Evaluate, design, optimize & implement the DPI Procedural Document (ProcDoc) Strategy in alignment with business objectives
  • Partner with critical quality & business representatives to drive the newly Quality Management System (QMS) module, more specifically Procedural Document Management System
  • Partner with Process Owners to design & implement well-defined process, ensuring integration of people, process and system components in business-critical ProcDocs
  • In collaboration with the business representatives, contribute to cross-functional process
    development & improvement initiatives
  • Act as a change agent supporting compliance and continuous improvement of critical business processes
  • Evaluate, design, optimize, implement the DPI Training & Learning Strategy and System in alignment with business objectives
  • Partner with critical quality & business representatives to drive the set up and implementation of the newly QMS module, more specifically Learning Management System
  • Establish and drive an effective role-specific learning and development structure and “just in time knowledge management” to enable the desired business results
  • Partner with Department Heads to ensure fit-for-purpose role-based training curricula are in place
  • Identify, evaluate, assess, and select external training vendors ensuring effective availability of effective training programs on specific topics
  • Act as a change agent supporting compliance and continuous improvement of DPI training activities in view of on-boarding and continuous learning.
  • Work with the Quality Leads to create and execute on engaging eLearning, instructor-led learning, virtual instructor-led learning based on experience from audit, inspection, CAPA and other sources
  • Ensure proper CAPA & KPI are developed and monitored
  • Training / Learning management

Your profile:

  • Master’s degree in a scientific discipline or equivalent combination of education and experience
  • Preferably 15 years’ experience in the Pharmaceutical or Biotechnology industry with a solid experience of at least 8-10 years in QMS in a GxP environment
  • Solid experience and expertise in design, harmonization, implementation, and optimization of cross-functional end-to-end business processes
  • Six Sigma certification/operational excellence and/or experience with process mapping tools and systems is desirable
  • Experience in understanding global regulatory GxP requirements and industry trends with the ability to apply them to process improvement
  • Experience in supporting Regulatory Inspection and Due Diligence activities
  • Significant experience with QMS tools, more specifically Procedural
    Document Management System and Learning Management System
  • Functional planning experience & ability to develop functional vision, priorities and tactics
  • Strong leadership, pragmatic collaboration and influencing skills in a complex, matrix environment
  • Experience in mentoring, coaching and directing people to ensure proper implementation of the management-endorsed strategy
  • Strong team player, with excellent interpersonal communication skills
  • Used to simultaneously support multiple projects, duties and assignments and prioritize accordingly
  • Self-dependent way of working; taking ownership of assigned tasks; plan and deliver according to agreed timelines
  • Proficiency in English (C1 Oral & written), fluent French is an asset

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