Job 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.