- 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.
- 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
* 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.
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