Career Category

Job Description

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics has changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives.

This position will be accountable for:

• Ensuring quality oversight of Amgen’s global product distribution and transportation from Amgen’s Global Supply Hubs to Amgen’s global markets.
• Providing QA oversight of Deviation process, CTETS and Distribution Complaints for Regional and Global Supply Chain operations

Responsibilities:

• IDQ subject matter expert on transportation related Quality Processes
• Perform QA contact role for Amgen Deviations, CTETS and Distribution Complaints
• Execute quality oversight of third party service provider Deviations
• Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements
• Play an active role as Quality advisor to in the selection/approval and oversight of distribution partners, suppliers and contracted service providers
• Perform QA contact role for transportation lane assessments
• Assist the business with the execution of Amgen responsibilities as established through Quality Agreements, regulation and Quality policies
• Manage Quality KPIs for Cold Chain related Quality Systems
• Develop reports and provide the necessary communications throughout the organization as required to ensure adequate understanding of Quality related topics
• Support Internal and External audit/inspection of Cold Chain related Quality Systems across regions
• Participate in global quality initiatives ensuring that IDQ input is provided

Basic Qualifications

• Doctorate degree OR
• Master’s degree and 2 years of directly related experience OR
• Bachelor’s degree and 4 years of directly related experience OR
• Diploma and 8 years of directly related experience

Preferred Qualifications and Competencies

• Experience in logistics/transportation industry
• Experience in working in an international environment
• Operational Excellence training and/or Industrial Engineering focus
• Knowledge of investigation tools for Root Cause Analysis
• Understanding logistics processes of parcel, transport and warehousing providers
• Good technical writing skills

Competencies

• Logical and linear analytical skills to evaluate and interpret complex situations/problems using multiple sources of information.
• Keeps overview but also deep dives when appropriate
• Effective communication skills at multiple levels and areas (inside and outside of Quality).
• Attention to detail.
• Good decision making skills and ability to apply risk based approach.
• Team player, constructively working together towards solutions.