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 Sanofi 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.
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
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