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.
ćResponsibilitiesć:
ā¢ Lead the QA department and play a crucial role in establishing, implementing, and maintaining Quality Management System.
ā¢ 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.
ā¢ Accountable for compliance with Amgen GxP, Policies and Procedures, and government regulations
ā¢ Confirm products to be dispositioned conform to applicable requirements including GQP ordinance requirements and perform disposition of products to Japan market.
ā¢ Manage GxP processes such as Batch Release, CAPA, Change Control Deviation, Self-inspection, Training, Complaint, Recall, Quality Agreement, Oversight on manufacturers etc.
ā¢ Contribute to Quality deliverables for Japan product launches, lifecycle events and other commercialization activities.
ā¢ Provide guidance and technical advice for PMDA Inspections that impact Amgen sites, as needed.
ā¢ Quality oversight of Contract Laboratories, Distributors and Logistic Service Providers as needed.
ā¢ 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.
ā¢ Engage with global teams to promote a clear understanding of Japanese regulatory requirements, regulatory authority expectations, and customer expectations.
ā¢ Work with global teams to share good practices and to drive continuous improvement initiatives.
ā¢ Act as a deputy of Head of Japan Quality and Quality Assurance Supervisor if needed.
ā¢ Contribute to the Amgen K.K. (AKK) mission, vision and strategy.
ćBasic Qualificationsć
ć»Doctorate +2, Masters +4, Bachelors +5 years of directly related experience in quality assurance and quality related activities in a global commercial operation.
ā¢ Demonstrated ability to effectively manage a partnership alliance, including relationship development and maintenance, negotiation skills and oversight to monitor health of partnership.
ćPreferred Qualificationsć
Managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
ā¢ Experience with Multi-National (MNCās) as well as Japanese pharmaceutical companies
ā¢ Experience working with biologics (monoclonal antibodies and/or proteins) and small molecule solid oral dosage forms in Japan
ā¢ Experience with Investigational Medicinal Products (IMP) and commercial products
ā¢ Experience with combination products in Japan
ā¢ Preferred candidate either lived and or worked aboard.
ā¢ Flexible to travel
ā¢ Experience in GMP audits of laboratories that perform analytical testing of biologics, LSPs and manufacturing sites.
ā¢ Pharmaceutical/ Biologics product commercialization and lifecycle management experience
ā¢ Strong verbal and written communication skills in English and Japanese.
ā¢ Knowledge of regulatory authority inspection processes
Confidential Quality Assurance
ā¢ Experience in Japan with multiple language capability (English, Japanese)
ā¢ Strong verbal and written communications skills. Must be able to effectively articulate ideas with all levels of an organization.
ā¢ Self-leadership and motivation with high personal integrity and application of Amgen Values in daily operations.
ā¢ Must have demonstrated interpersonal skills, including temperament, objectivity and approach that will facilitate effective interactions with a team of seconded staff
ā¢ Ability for travel to international destinations as needed
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