Vaccines Qms, Process and Training Coordination

vor 2 Wochen

Zürich, Zürich, Schweiz Takeda Vollzeit

OBJECTIVES:

  • The QMS, Process and Training Manager is responsible for the coordination of activities and implementation of actions related to the maintenance and development of procedural documents related to the delivery of clinical studies, including process changes.
  • Ensures VBU Development & GMA contribution to controlled document development.
  • Coordinates implementation of training initiatives in VBU Development & GMA, manages training process for VBU GMO and tracks training status.
  • Supports Learning and Data Management System (SAP SuccessFactors and Veeva Quality Docs) as lead user.

ACCOUNTABILITIES:

QMS Responsibilities

  • Leads and facilitates implementation of Quality Management Systems (QMS) with the VBU Development & GMA review team, including the creation and maintenance of team charter, organisation of periodic meetings and follow up on post meeting actions
  • Tracks and maintains the lifecycle of procedural documents creation, review, editing, approval, posting, tracking, and maintenance; manage notifications regarding new, revised, or terminated procedural documents to respective users
  • Serves as the feedback channel for clinical processes, initiates and coordinates change management with process owners and tracks progress
  • Acts as counterpart to Takeda R&D Process Managers
  • Communicates with VBU Development & GMA process owners and with Clinical QA on an ongoing basis, recommends actions/ solutions for the implementation of new/changed processes and the management of eventual issues
  • Coordinates crossfunctional review for VBU Development & GMA controlled documents.
  • Ensures that changes to QMS documents are evaluated for impact to other documents.
  • Supports the preparation for, and responses to audits and regulatory inspections in areas related to procedural documents and processes
  • Communicates within VBU Development & GMA relevant new developments, initiatives and information related to VBU QMS
  • Serve as the lead user and contributes to the implementation of Data Management Systems and Learning Management Systems (e.g. Veeva) and promotes user acceptance

Training Responsibilities

  • Coordinates Development on maintaining training grid, identification and organisation of training according to training needs
  • Reviews the monthly Compliance reports and communicates compliance status.
  • Support Vaccines Quality Team in maintaining training matrix for VBU Development & GMA
  • Responsible for appropriate training assignment for new hires in VBU Development & GMA
  • Ensures training documentation for nonLEADS users is regularly updated and distributed via Process and Training SharePoint

Other tasks

  • Maintains the Process and Training SharePoint
  • Ensures training documentation for nonLEADS users is regularly updated and distributed via Process and Training SharePoint

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Fluent knowledge of spoken and written English.
  • Selforganization, time management skills, structured way of working
  • At least 5 years experience in the pharmaceutical industry, preferably in Clinical Development/ Quality Assurance/Vaccines
  • Understanding of the skills and knowledge required for the successful delivery of a clinical study, eg. ICH-GCP, study management, site management, monitoring
  • Knowledgeable of local and international regulations and guidelines
  • Able to communicate clearly across a broad range of stakeholders.

Locations:

Zurich, Switzerland

Worker Type:

Employee

Worker Sub-Type:

Regular

Time Type:

Full time

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