This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
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. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. 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.
Job Responsibility:
Address and close quality records under the company's quality management system procedures and ensure compliance with regulatory agency requirements
Mentoring and leading of peers in functional areas and Quality Operations in the implementation of investigations of varying complexity
Facilitation of cross-functional teams (internal and external to the site) with the goal of achieving robust and detailed investigation performance
Monitor, author, and investigate deviations owned by External Supply and implements corrective / preventive actions
Partner cross-functionally across the site to ensure maturity and execution of robust Deviations / CAPA process
Lead investigation teams to identify meaningful root causes and robust corrective and preventative actions by effectively utilizing advanced root cause analysis tools (Causal Factor Analysis, Fault Tree Analysis, Kepner-Tregoe, etc.)
Manages closure of multiple quality records simultaneously and in a timely matter (Deviations, Change Controls, ENs, SICARs, CAPA, CAPA-EV)
Work closely with the suppliers and External Supply peers to address and close critical investigations and Corrective Actions
Build and present quality records summaries for Senior Management review
Provide timely and comprehensive process and status updates to senior management
Communication of Quality records status to Senior Leadership in multiple forums (as requested)
maintaining the metric reporting for performance
May participate in regulatory inspections
Participate in the assessment or implementation of continuous improvement projects or initiatives
Meet deadlines, prioritize work, and communicate effectively
Maintain remote working relationships with colleagues at other Amgen sites
Leads process improvement initiatives
Requirements:
Doctorate degree
Master’s degree & 2 years of Manufacturing and/or Quality support experience
Bachelor’s degree & 4 years of Manufacturing and/or Quality support experience
Associate’s degree & 8 years of Manufacturing and/or Quality support experience
High school diploma / GED & 10 years of Manufacturing and/or Quality support experience
Nice to have:
3+ years related work experience (manufacturing, process development, or quality assurance) in Biotech or pharmaceutical industry with progressively increasing responsibility and demonstrated experience in compliance, problem solving, critical thinking, project management, and quality systems
Live Science and/or Engineering educational background
Project management and technical writing experience
Quality management skills including previous experience managing quality records in Trackwise or a comparable quality system
SAP system knowledge
Experience in leading multiple, contending priorities in a fast-paced environment with minimal direction
Excellent communication skills, both written and verbal in English (including technical writing and presentation skills)
Experience presenting to and interacting with representatives of regulatory agencies
Proficient with Microsoft Office Tools (Word
Excel
PowerPoint
Project, Teams, Outlook)
Ability to tactfully negotiate and positively influence peers and executive leadership
Previous experience managing external suppliers
What we offer:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
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