144,375.00 usd - 168,313.00 usd; not specified; no...
Gmp/gdp inspection lifecycle management
Global process leadership
Regulatory commitment tracking
Amgen's shared mission is to serve patients living with serious illnesses by researching, manufacturing, and delivering innovative medicines
Job Summary
Amgen's shared mission is to serve patients living with serious illnesses by researching, manufacturing, and delivering innovative medicines.
This role leads the design, governance, and continuous advancement of the end-to-end GMP/GDP inspection lifecycle, ensuring consistent and compliant practices globally.
Amgen offers a comprehensive employee benefits package, including a Retirement and Savings Plan, health and welfare plans, and award-winning time-off plans.
Matching Summary
Amgen's shared mission is to serve patients living with serious illnesses by researching, manufacturing, and delivering innovative medicines.
Salary
144,375.00 USD - 168,313.00 USD; Not specified; Not specified
Skills & Requirements
Must-have
GMP/GDP inspection lifecycle management
Global process leadership
Regulatory commitment tracking
DQMS Operations Inspection module
Cross-GxP inspection alignment
Global inspection metrics control plan
Nice-to-have
Collaborative, innovative, science-based culture
Passion for challenges
Continuous improvement mindset
Industry benchmarking and research
Key Requirements
Doctorate degree and 2 years of Quality/Operations/Regulatory Compliance experience
Master’s degree and 4 years of Quality/Operations/Regulatory Compliance experience
Bachelor’s degree and 6 years of Quality/Operations/Regulatory Compliance experience
Associate’s degree and 10 years of Quality/Operations/Regulatory Compliance experience
High school diploma/GED and 12 years of Quality/Operations/Regulatory Compliance experience
Prior experience leading GMP/GDP inspections
Deep knowledge of global health authority inspection expectations