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.
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