Deputy Country Quality Head

3日前

Location: Tokyo, Tokyo JP Randstad Sourceright

Job Number:

External Description:

  • Key Accountabilities
  • Country Quality System management
  • Lead the implementation and maintenance of GxP quality system with respective operation units, the continues quality system implementation for competencies and related Quality documentation of GxP area: medical, pharmacovigilance, regulatory and clinical.
  • Deviation and CAPA management: oversight deviation and CAPA management by GxP owner functions including the subcontractor audit/ inspection findings.
  • Change Control management: oversight the change process which may impact GxP or health-regulated process or operations by leading multidisciplinary exchange and action plans if necessary.
  • Country Quality Agreement: as required ensure the valid and signed quality agreements containing quality dispositions and other mandatory quality related clause are in place.
  • Ensure and maintain the local computerized system inventory.
  • Document Management
  • Organize the implementation and consistent management of the country quality documentation though a global system.
  • Assessment of global quality documents and implementation into local operations.
  • Ensure required quality documents are in-place, in-use and up to date.
  • Country Quality Audit and Inspection
  • Ensure a quality oversight for all GxP functions and provide support as required during inspection or audit.
  • Define, implement and maintain the local key GxP subcontractor list periodically, coordinate and complete for GxP subcontractors based on the annual audit plan which are provided by the risk management criteria.
  • Ensure certified auditors complete the planned annual GxP audit plan in place.
  • Evaluate the GxP audit findings trend to define the affect the country quality system and communication with global if needed.
  • Evaluate new GxP subcontractors Quality Due Diligence activities before business use.
  • Product Alert
  • Manage Quality Product alerts in Japan as well ensuring operational support in case of recall in close collaboration with other stakeholders including manufacturing.
  • Training
  • Organize and manage information sharing, training sessions or programs for talent development in the division according to standards and regulatory requirements.
  • Country Quality Review
  • Carry-out an annual Country Quality Review and organize the related meeting to present the outcomes to Country Senior Management Board
  • Quality Key performance indicators
  • Monitor and periodically report country KPIs along with global KPI indicators guideline using the global computerized system.
  • Non-product quality events
  • Escalate and inform the events occurring at the country/ global MCCQ according to Products alert team/ Local crisis management team procedure.
  • GQP requirement
  • Ensure GQP team activities along with local regulatory requirements and escalation for quality events as necessary.
  • Quality Culture
  • Enhance quality culture across the Japanese commercial entities.
  • About you
  • Your Education, Qualification & Experience
  • Pharmacist License
  • Scientific degree in science, medicine, or Pharmacy
  • Minimum 5 years Leadership experience in Quality at an industrial (Pharma or food is preferred) site
  • GxP and health-related regulations knowledge in production and development of active substances, drug product and drug device combination products as also medical devices.
  • Practical and solid experience of minimum 10 years in Quality System Management in health-regulated industry.
  • Knowledge in Auditing, Process validation, Quality Assurance, Quality Control, Regulatory Affairs, Quality Risks Management, Quality Systems domains.
  • Experience in Negotiation, Project Management, Networking and Problem Solving
  • International exposure
  • Your Language Skills
  • Japanese speaking required.
  • English speaking required (written & verbal)
  • Your Competencies
  • Leadership: change management, managerial courage/ fearlessly dealing with trouble Team spirit. Develop People. Transversal cooperation – customer committed
  • Driver of change: willing to challenge "conventional" thinking and ways of working – striving for results
  • Well organized, resourceful; effective and efficient at marshaling multiple resources to get things done; can work on multiple tasks at once without losing track; foresees and plans around obstacles
  • Stress tolerance, ability to manage critical situations.
  • Ability for strategic thinking and having predictions for Quality evolution.

    • Job Number:

    Community / Marketing Title:
    Deputy Country Quality Head

    Location_formattedLocationLong:
    Tokyo, Tokyo JP

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