Sr Manager QA - QVTS

About the role

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Responsibilities

• Lead activities associated with quality oversight of the design, installation, commissioning & qualification and process qualification of the new facility and equipment.
• Collaborate cross-functionally through all stages (construction, facility start-up, operational readiness, operations) to ensure project timelines and landmarks are met.
• Lend quality expertise and guidance to strategic and tactical decisions, ensuring both efficiency and compliance in business and operational processes.
• Partner with Manufacturing, Facilities & Engineering and other support functions providing coaching, guidance and direction on cGMP processes, procedures, protocols, assays, documents, records, quality systems, and compliance aspects.
• Ensure the design of the facilities and equipment, materials, organization, processes, procedures and products stay in sync with cGMP requirements and other applicable regulations.
• Provide quality and compliance expertise and agree on execution strategies related to the design, installation, commissioning & qualification and process qualification of the new facility, equipment, and information systems.
• Directly support and provide leadership for quality review and approval of documents to support facility commissioning and qualification, according to project timelines.
• Ensure the Quality unit provides review, approval and tracking of cGMP processes, procedures, protocols, assays, documents and records including but not limited to Work Orders, Deviations, CAPA's, and Change Controls.
• Ensure that all activities & related documentation for facilities, equipment, materials and processes align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
• Identify and drive implementation of continuous improvement opportunities.
• Collaborate cross functionally and across the Amgen Enterprise/Network to ensure the Quality Management System processes are implemented, maintained and carried out in accordance with established procedures and applicable regulations.
• Build and manage a strong team of Quality professionals that will partner effectively and provide quality oversight for the current and new facilities in the future.
• Ensure deviations from established procedures are investigated and documented per procedures.
• Represent the quality unit during audits and inspections as needed.

Requirements

• High school diploma / GED and 12 years Quality and/or Operations experience OR
• Associate’s degree and 10 years of Quality and/or Operations experience OR
• Bachelor’s degree and 8 years of Quality and/or Operations experience OR
• Master’s degree and 6 years of Quality and/or Operations experience OR
• Doctorate degree and 2 years of Quality and/or Operations experience
• Minimum of 2 years’ experience directly managing