_{23rd April, 2025}

Summary
 
Oversee, manage and coordinate all operational aspects of ongoing department projects impacting multiple departments. Serves as liaison between project team and department.
 
Responsabilities

• In a GMP environment, design, conceive, progress and implement new or changes to existing customer facing (SKUs) change records (CFSCRs) within the Change Control Management quality system.
• In a GMP environment, design, conceive, progress and implement variants of product structures or intermediate SKUs to enable supply chain flow of product within the fill and finish site within the Change Control Management quality system.
• Interpret strategies and navigates through artwork, regulatory GMP systems and applicable technical assessments to ensure a compliant change is developed, prioritized, and progressed through all product stages in compliance with the respective guidelines and procedures.
• Makes sound decisions and projects adjustments based on data from Regional Operations Leads, planning tools, production planners, inventory scrap costs and resources capacity utilization.
• Supports manager in leading all aspects of project(s) within Supply Chain: planning, implementation, monitoring, follow-up, completion, and business partner meetings.
• Reports, communicates and presents metrics on variations implementations, launch completions and other activities related to the life cycle management of the Amgen products.
• May complete specific supply chain readiness projects and business cases.

• Doctorate degree OR Master's degree and 2 years of Project Management experience OR Bachelor's degree in Life Sciences, Engineering, Material Management, Sciences, and related and 4 years of Project Management experience OR Associate’s degree and 10 years of Project Management experience OR High school diploma / GED and 12 years of Project Management experience.
• Hands-on experience with change control processes and systems. Focused on commercial product life cycle, manufacturing, product variations and/or new product introduction.
• Demonstrated ability on project management skills in balancing multiple responsibilities, priorities, tasks, and projects simultaneously.
• Experience on Quality roles
• Quality contact for change controls and or deviations
• Knowledge of SAP and Bill of material (BOM) management
• Experience with Regulatory field
• Strong organizational skills, diligent and accurate, analytical
• Fluent and highly proficient in English and Spanish communication skills (verbal and written) as peers will communicate in English across multiple countries
• Writing skills
• Experience on managing quality systems and/or managing deviations (non-conformances).
• Experience in scheduling and coordination around production schedules.
• Smartsheet knowledge, TrackWise (or equivalent quality or change control management) preferred, MS Office