Senior Director of Quality Assurance

Tokyo Permanent ¥18,000,000 - ¥26,000,000
  • Join the fast growing global Biotech known for mRNA therapeutics.
  • Build out the QA organization from scratch in newly established Japan business.

About Our Client

  • Client is one of the hottest growing companies globally and looking to make a huge and immediate impact in Japan with their COVID-19 vaccine.
  • The company builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinical phase.

Job Description

  • Serve as the Company's Management Representative. Key responsibilities includes;
    * Implementation and maintenance of the company's quality system.
    * Preparation of Quality Reviews and the monitoring of Quality related KPIs.
    * Develop and administer department budgets, schedules, and other administrative functions.
    * Creation, update and application of procedural documents (SOPs).
    * Preparation of internal and external audits, inspections, certifications and monitoring of associated CAPAs for
    manufacturing (GMP).
    * Support, as requested for GCP, GVP inspections.
    * Reporting to the Pharmaceuticals and Medical Devices Agency (PMDA).
    * Risk analysis and management of vaccine/pharmaceutical subcontractors: ensuring that the transportation conditions guarantee the appropriate conservation, integrity and security of the products.
    * Monitoring of medical samples.
    * Implementation and monitoring of the distribution system (contracts, specifications, etc.)
    * Stock monitoring (stock forecast, authorisation to distribute, declaration in the event of a risk or confirmed
    shortage, transport conditions, batch recall, returns, etc.)

The Successful Applicant

  • Graduated as Pharmacist +10 years of experience within the pharmaceutical industry (quality, regulatory and pharmacovigilance area).
  • Fluent Japanese.
  • Fluent business English.

What's on Offer

  • Equity package included.
  • Number of leadership teams.
Max Kuroiwa
Quote job ref

Job summary

Contract type
Consultant name
Max Kuroiwa
Job reference