Quality Compliance, Director

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions.

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.

Let’s do this. Let’s change the world. In this vital role you will reporttothe

Executive Director of Regulatory Compliance and primarily provide direct support forcompliancerelated deliverables associated to new sites or expansion of existing manufacturing sites.

• Serve as a strategic partner supporting the Quality Improvement Plans(QIP) and Operational Readiness program by providing independent compliance expertise, and objective guidance to support sustained GMP readiness and operational excellence.
• 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, andGo/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/orreview regulatory communication sin the form ofinspectionobservationresponses,third party audit finding responses,responses to questionsassociatedwithregulatoryfilingsand other information requests.
• Conduct inspection readiness exercises(strategy, preparation, pressure testing) in support of both scheduled and unscheduled regulatory inspections, in coordination withthesites andSite Inspection Lifecycle Management  staff.
• Assist with 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 supportfordeviation investigationandkeyinspection topics.
  
  Ensure appropriate technical content and documented rationale is available in support of investigation conclusions.
  
  Participate on Investigation Advisory Boards as Advisor, as required.
• Provide compliance advice onnew technologies and proposed changes to quality processes in support of continuous improvement and the implementation of new digital strategies.

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a person with these 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.

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and…