Manager QA - Global Supply Quality

In this role, you will serve patients through internal collaboration with Amgens global quality teams, manufacturing sites, commercial supply chains, Amgen affiliates, and Amgen External Partners. You will contribute to ensuring high-quality and right-first-time quality systems activities at Amgen, build and support a resilient supply network, and conclude with a positive patient experience.

The Manager of Quality Assurance, Global Supply Quality will support the implementation and management of quality assurance activities at the Amgen Technology and Innovation Center, as well as will be responsible for leading a team of quality professionals who will maintain and approve various quality documents, including but not limited to Quality documentation and metrics, change control, investigations, CAPA, audit records, quality agreements and other supplier, service provider, and partner related documentation. The team of quality professionals will also own key aspects of the ERP System (SAP) Master Data for suppliers, managing system changes following Amgen standards. This role will involve collaboration with various internal Amgen teams and External Partner teams to ensure seamless handoffs.

• Oversee a group of 5 to 10 staff, ensuring their activities and priorities are managed in a compliant, structured manner.
• Ensure team members are appropriately qualified and trained to perform activities per company policies and procedures.
• Conduct goal setting, performance reviews, and compensation planning.
• Develop, implement, and maintain the quality records in compliance with industry standards and regulatory requirements.
• Drive continuous improvement to enhance efficiency and quality by applying lean principles and automation
• Analyze data and metrics to identify trends and areas for improvement within the quality systems and business processes.
• Provide support for domestic and foreign agency site inspections across the Amgen Network and with our Partners.
• Work multi-functionally with various Amgen teams and collaborators to ensure seamless transition of tasks and continuity across groups.
• Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
• Complete team tasks as needed to support business needs.

• Interact with functional leads to ensure operational standards, strategies, and goals meet regulatory expectations.
• Collaborate with various groups to ensure alignment with organizational objectives.

• Doctorate degree OR
• Masters degree with 4 to 6 years of experience in quality management systems or a related field OR
• Bachelors degree with 6 to 8 years of experience in quality management systems or a related field OR
• Diploma with 10 to 12 years of experience in quality management systems or a related field.
• 2+ Experience Managing Staff in a GxP environment

• Technical Proficiency: Strong knowledge of technical writing tools and software, including MS Word, MS Excel, SharePoint, and Veeva platform. Familiarity with ERP systems (ex SAP).
• Quality Proficiency: Working foundation in quality assurance roles and proven team leader managing staff in a GxP environment. Solid understanding of regulatory requirements and expectations, and how it links to a robust Quality Management System and documentation.
• Attention to Detail: Ability to meticulously review and edit documentation to ensure accuracy and consistency.
• Communication: Excellent verbal and written communication skills, with the ability to effectively collaborate with various groups and resolve discrepancies. The ability to affect behaviors of others by connecting and inspiring them.
• Organizational Skills: Strong ability to prioritize tasks, manage multiple projects and tasks simultaneously, and meet deadlines. High degree of initiative and self-motivation.
• Adaptability: Ability to quickly grasp new concepts and react to changes in a rapidly evolving environment.
• Teamwork: Ability to work well with others and contribute to a positive team environment. Ability to work effectively with global, virtual teams. Ability to build and lead a team, and help the team navigate change.
• Problem-solving: Strong analytical skills to identify and resolve documentation-related and quality system related issues.
• Customer Focus: Commitment to understanding and meeting the needs of internal and external key collaborators as a quality leader.