QA Sr. Manager

The Senior Manager of Quality Assurance at Amgen leads the QA department and plays a crucial role in establishing, implementing, and maintaining the Quality Management System. They ensure the organization's compliance with regulatory standards and drive continuous improvement initiatives.

【Responsibilities】

• Lead the QA department and play a crucial role in establishing, implementing, and maintaining Quality Management System.
• Establish drug GQP and QMS operating policies and organizational structure per Amgen GxP, Policies and Procedures, and government regulations- products may include sterile injectable monoclonal antibodies and proteins in vials, syringes and devices and small molecules in solid oral dosage form.
• Accountable for compliance with Amgen GxP, Policies and Procedures, and government regulations
• Confirm products to be dispositioned conform to applicable requirements including GQP ordinance requirements and perform disposition of products to Japan market.
• Manage GxP processes such as Batch Release, CAPA, Change Control Deviation, Self-inspection, Training, Complaint, Recall, Quality Agreement, Oversight on manufacturers etc.
• Contribute to Quality deliverables for Japan product launches, lifecycle events and other commercialization activities.
• Provide 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.
• 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.
• Engage with global teams to promote a clear understanding of Japanese regulatory requirements, regulatory authority expectations, and customer expectations.
• Work with global teams to share good practices and to drive continuous improvement initiatives.
• Act as a deputy of Head of Japan Quality and Quality Assurance Supervisor if needed.
• Contribute to the Amgen K.K. (AKK) mission, vision and strategy.

• 【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.

• 【Preferred Qualifications】
• 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 combination products in Japan
• Preferred candidate either lived and or worked aboard.
• Flexible to travel
• Experience in GMP audits of laboratories that perform analytical testing of biologics, LSPs and manufacturing sites.
• Pharmaceutical/ Biologics product commercialization and lifecycle management experience
• Strong verbal and written communication skills in English and Japanese.
• Knowledge of regulatory authority inspection processes

Confidential Quality Assurance

• 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