Global GMP/GDP Audit & Predictive Compliance Leader

Amgen Inc. (IR); Northern (KY); Hybrid; USD 260,000 - 320,000; Full time

Benefits offered by this job

Total Rewards Plan

Flexible work models

Stock-based long-term incentives

Retirement & Savings Plan

Job summary

Amgen Inc. is seeking a Senior Director to lead the global GMP/GDP audit organization and predictive compliance intelligence capability.

You will set strategic direction, governance, and a multiyear roadmap, directing audits of sites, suppliers, and quality systems while building predictive analytics to guide audit priorities and risk mitigation. You will develop a data-driven enterprise risk view, integrate regulatory trends, and lead a global, multidisciplinary team with emphasis on

Qualifications

• Experience leading global GMP/GDP audit programs and predictive compliance initiatives.
• Strong background in operations GMP/GDP compliance and quality systems.
• Proven ability to build enterprise risk views and predictive models.

Responsibilities

• Lead global GMP/GDP audit organization and predictive compliance intel.
• Develop strategic direction, governance, and multiyear roadmaps.
• Oversee risk-based audit strategy, master schedule, and CAPA follow-up.
• Integrate audit data, regulatory trends, and supplier performance into risk view.
• Build AI-enabled tools for risk detection while maintaining human judgment.

Skills

Leadership

Global audit strategy

Predictive analytics

AI-enabled tools

Regulatory intelligence

Quality systems

Cross-functional collaboration

Risk management

Education

Doctorate in Biologics/related field

Master’s in related field

Bachelor’s in related field

Tools

AI-enabled audit tools

Analytics platforms

Regulatory intelligence platforms

Job description

Amgen Inc. is seeking a Senior Director to lead the global GMP/GDP audit organization and predictive compliance intelligence capability.

You will set strategic direction, governance, and a multiyear roadmap, directing audits of sites, suppliers, and quality systems while building predictive analytics to guide audit priorities and risk mitigation. You will develop a data-driven enterprise risk view, integrate regulatory trends, and lead a global, multidisciplinary team with emphasis on