Amgen Quality Assurance Sr Mgr in Tokyo, Japan

Job Posting Title

Quality Assurance Sr Mgr

Amgen 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 the Amgen-Astellas BioPharma (AABP) mission, vision and strategy

  • Contributes to Quality deliverables for Japan product launches, lifecycle events and other commercialization activities

  • Accountable for compliance with Amgen GxP, Policies and Procedures, and government regulations

  • Provides guidance and technical advice for PMDA Inspections that impact Amgen sites, 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 Amgen. 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 GxP, product testing and Japanese Pharmacopoeia requirements; as delegated, represent Amgen in key industry groups in Japan and provide Amgen 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.

  • Self-leadership and motivation with high personal integrity and application of Amgen Values in daily operations.

  • 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

Preferred Qualificatio ns

  • Managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

  • Experience with Multi-National (MNC's) as well as Japanese pharmaceutical companies

  • Experience working with biologics (monoclonal antibodies and/or proteins) and small molecule solid oral dosage forms in Japan

  • Experience with Investigational Medicinal Products (IMP) and commercial products

  • Experience with Class 3 medical devices in Japan

  • Preferred candidate either lived and or worked aboard.

  • Flexible to travel

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