QA Sr. Manager

<h2><b>Career Category</b></h2>Quality<h2></h2><h2><b>Job Description</b></h2><p>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&#39;s compliance with regulatory standards and drive continuous improvement initiatives.</p><p></p><p>【Responsibilities】:<br />• Lead the QA department and play a crucial role in establishing, implementing, and maintaining Quality Management System.<br />• 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.<br />• Accountable for compliance with Amgen GxP, Policies and Procedures, and government regulations<br />• Confirm products to be dispositioned conform to applicable requirements including GQP ordinance requirements and perform disposition of products to Japan market.<br />• Manage GxP processes such as Batch Release, CAPA, Change Control Deviation, Self-inspection, Training, Complaint, Recall, Quality Agreement, Oversight on manufacturers etc.<br />• Contribute to Quality deliverables for Japan product launches, lifecycle events and other commercialization activities.<br />• Provide guidance and technical advice for PMDA Inspections that impact Amgen sites, as needed.<br />• Quality oversight of Contract Laboratories, Distributors and Logistic Service Providers as needed.<br />• 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.<br />• Engage with global teams to promote a clear understanding of Japanese regulatory requirements, regulatory authority expectations, and customer expectations.<br />• Work with global teams to share good practices and to drive continuous improvement initiatives.<br />• Act as a deputy of Head of Japan Quality and Quality Assurance Supervisor if needed.<br />• Contribute to the Amgen K.K. (AKK) mission, vision and strategy.</p><p></p><p>【Basic Qualifications】</p><p>・Doctorate &#43;2, Masters &#43;4, Bachelors &#43;5 years of directly related experience in quality assurance and quality related activities in a global commercial operation.<br />• Demonstrated ability to effectively manage a partnership alliance, including relationship development and maintenance, negotiation skills and oversight to monitor health of partnership.</p><p></p><p>【Preferred Qualifications】</p><p>Managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources<br />• Experience with Multi-National (MNC’s) as well as Japanese pharmaceutical companies<br />• Experience working with biologics (monoclonal antibodies and/or proteins) and small molecule solid oral dosage forms in Japan<br />• Experience with Investigational Medicinal Products (IMP) and commercial products<br />• Experience with combination products in Japan<br />• Preferred candidate either lived and or worked aboard.<br />• Flexible to travel<br />• Experience in GMP audits of laboratories that perform analytical testing of biologics, LSPs and manufacturing sites.<br />• Pharmaceutical/ Biologics product commercialization and lifecycle management experience<br />• Strong verbal and written communication skills in English and Japanese.<br />• Knowledge of regulatory authority inspection processes<br />Confidential Quality Assurance<br />• Experience in Japan with multiple language capability (English, Japanese)<br />• Strong verbal and written communications skills. Must be able to effectively articulate ideas with all levels of an organization.<br />• Self-leadership and motivation with high personal integrity and application of Amgen Values in daily operations.<br />• Must have demonstrated interpersonal skills, including temperament, objectivity and approach that will facilitate effective interactions with a team of seconded staff<br />• Ability for travel to international destinations as needed</p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>.