Quality Compliance, Director

About the Role

At Amgen, our shared mission to serve patients living with serious illnesses drives all that we do. As a Director of Quality Compliance, you will report to the Executive Director of Regulatory Compliance and primarily provide direct support for compliance-related deliverables associated with new sites or expansion of existing manufacturing sites. This role involves serving as a strategic partner supporting Quality Improvement Plans (QIP) and the Operational Readiness program by providing independent compliance expertise and objective guidance to support sustained GMP readiness and operational excellence.

Responsibilities

• Partner closely with QA Operational Readiness Team and cross-functional leadership to evaluate remediation strategies, operational readiness initiatives, and quality system enhancements, ensuring alignment with global quality standards, regulatory expectations, and enterprise best practices.
• Participate in operational readiness reviews and Go/No-Go decision-making processes to support objective, evidence-based assessments while promoting inspection readiness, effective risk management, and the long-term sustainability of the site's Quality Management System.
• Draft and/or review regulatory communications in the form of inspection observation responses, third-party audit finding responses, responses to questions associated with regulatory filings, and other information requests.
• Conduct inspection readiness exercises (strategy, preparation, pressure testing) in support of both scheduled and unscheduled regulatory inspections, in coordination with the sites and Site Inspection Lifecycle Management staff.
• Assist with the generation of inspection playbooks and ensure staff are prepared to present during regulatory inspections.
• Lead virtual or on-site strategy support during regulatory inspections. May lead cross-functional regulatory response teams.
• Provide direct compliance support for deviation investigation and key inspection topics. Ensure appropriate technical content and documented rationale is available in support of investigation conclusions.
• Participate on Investigation Advisory Boards as an Advisor, as required.
• Provide compliance advice on new technologies and proposed changes to quality processes in support of continuous improvement and the implementation of new digital strategies.

Qualifications

Basic Qualifications

• Bachelor’s degree and 9 years of Quality Compliance experience
• OR Master’s degree and 7 years of Quality Compliance experience
• OR Doctorate degree and 4 years of Quality Compliance experience

Preferred Qualifications

• Strong background in Quality Compliance within a GMP-regulated environment.
• Experience supporting drug substance and bulk manufacturing operations.
• Expertise in GMP compliance, inspection readiness, and regulatory requirements.
• Experience with drug product manufacturing and compliance.

Benefits

Amgen offers 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.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models where possible.

Pay

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.