QA Sr. Manager
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Job Summary
Career Category
QualityJob Description
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 organizations 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 (MNCs) 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
Required Experience:
Manager
Key Skills
- Quality Assurance
- FDA Regulations
- Food Industry
- Food Safety Experience
- ISO 9001
- Quality Systems
- Food Processing
- Quality Control
- Quality Management
- QA/QC
- Selenium
- HACCP
About Company
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the ... View more
