Location: Japan - Tokyo
Job Type: Permanent
Salary: 8000000 - 12000000 JPY
Job Function: QA/QC
Reference: JO-180323-150106
Industry: Life Sciences & Healthcare
Sub-Industry: Pharmaceuticals






Job Description

Responsibilities include, but not limited to:

  • Establishes drug GQP and device QMS operating policies per the Pharmaceutical Affairs Law - products may include sterile injectable monoclonal antibodies and proteins in vials, syringes and devices; and small molecules in solid oral dosage form
  • Contributes to Quality deliverables for Japan product launches, lifecycle events and other commercialization activities
  • Accountable for the compliance, Policies and Procedures, and government regulations
  • Provides guidance and technical advice for PMDA Inspections, as needed
  • Quality oversight of Contract Laboratories, Distributors and Logistic Service Providers as needed
  • Oversight of the CMO
  • Accountable for implementation of Quality Management System per ICH Q10 and PAL; to include Information Systems, GMP Procedures and Policies and Training Curriculum
  • Quality oversight and Audit program management for key Japanese suppliers to the company. These suppliers may include final packaging materials suppliers and service providers.
  • Development and management of the GMP Intelligence Program to assess and monitor Japanese regulations, standards and guidance documents related to it, product testing and Japanese Pharmacopoeia requirements; as delegated, represent the key industry groups in Japan and provide the stakeholders with guidance and interpretation on these requirements.

Basic Qualifications

  • Doctorate +2, Masters +4, Bachelors +5 years of directly related experience in quality assurance and quality related activities in a global commercial operation.
  • Demonstrated ability to effectively manage a partnership alliance, including relationship development and maintenance, negotiation skills and oversight to monitor health of partnership
  • Experience performing GMP audits of laboratories that perform analytical testing of biologics, LSPs and packaging suppliers.
  • Pharmaceutical/ Biologics product commercialization and lifecycle management experience
  • Strong verbal and written communication skills in English and Japanese.
  • Knowledge of regulatory authority inspection processes
  • Experience in Japan with multiple language capability (English, Japanese)
  • Strong verbal and written communications skills. Must be able to effectively articulate ideas with all levels of an organization.
  • Must have demonstrated interpersonal skills, including temperament, objectivity and approach that will facilitate effective interactions with a  team of seconded staff
  • Ability for travel to international destinations as needed