Quality Assurance Senior Manager

Basic Qualifications:
Doctorate degree with 2 years of experience in the relevant discipline/sub-discipline
Masters degree with 6 years of experience
Bachelors degree with 8 years of experience
Associate degree with 10 years of experience
High school diploma/GED with 12 years of experience

This position requires strong critical thinking with a global mindset as well as requires the ability to operate with a high degree of autonomy and accountability to drive execution within the required accelerated timelines. The position will provide comprehensive support to the companies Global Process Owner (GPO) for Recalls, Regulatory Reporting, and Disposition. This role is responsible for the day-to-day execution and coordination of global Quality Management System (QMS) activities and continuous improvement initiatives related to these key quality processes. The EW will ensure and support program alignment, consistency, and effective communication across the global network while supporting the companies commitment to cGMP compliance and product quality.

Day to Day Responsibilities:
• Lead and facilitate GPO network activities including scheduling, developing agendas, preparing materials, and maintaining meeting minutes and action tracking to ensure effective execution and follow-up on commitments.
• Author, review, and edit key program documents, including procedures, process guides, and reports to ensure clarity, accuracy, and alignment with Amgen’s quality standards and regulatory requirements.
• Collaborate with regional and global network members to deploy and sustain process improvements, ensuring alignment with GPO strategy, quality objectives, and continuous improvement initiatives.
• Perform data analysis and critical assessments of process metrics and trends to identify and communicate opportunities for continuous improvement and risk mitigation across Recall, Regulatory Reporting, and Disposition programs.
• Collaborate with global SMEs and functional representatives to drive process alignment, ensure adherence to the established program structure, and maintain consistency across regional implementations.
• Support the GPO in execution of strategic initiatives, including process harmonization, documentation standardization, and improvement projects to enhance global quality system effectiveness.
• Initiate, investigate/author, and approve program-related deviations, change controls, and CAPAs, ensuring timely closure and thorough documentation in compliance with cGMP and internal procedures.
• Maintain oversight of process performance metrics through timely data collection, analysis, and reporting to support management reviews and continuous improvement tracking.
• Perform historical analyses of product analytics related to the recalls, regulatory reporting, and disposition processes to prepare comprehensive reports, identify trends, and provide data-driven insights to the GPO and key stakeholders.
• Communicate proactively with stakeholders to ensure transparency and engagement in process decisions, escalations, and improvement outcomes.

Secondary / Support Responsibilities
• Provide quality oversight and guidance on recall execution, regulatory reporting activities, and product disposition to ensure compliance with applicable global regulations and Amgen policies.
• Participate in cross-functional quality forums and initiatives to share best practices and drive network-wide process excellence.
• Assist in maintaining inspection readiness and supporting documentation for internal audits, HA inspections, and corporate assessments.
• Coordinate and manage process readiness activities to ensure inspection preparedness and alignment with internal and external audit expectations.