Senior Manager Corporate Quality Compliance

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. 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.

Responsible for executing Global Quality Compliance assigned tasks and/or projects necessary to achieve corporate and departmental goals including the following activities:

• Coordinates and leads or participates in Global Quality Compliance Audits of Corporate Quality Management System, Amgen sites, Contract facilities, Affiliates, Critical Service Providers, Suppliers, Partners, and Wholesalers to assess compliance with all applicable regulations and to identify top compliance risks.

• Ensure completion, maintenance, and sustainability of the assigned training per specific roles to support the audit process (e.g., read and understand how to apply regulatory requirements including changes to regulations, guidelines and standards, trends and expectations, as applicable).

• Supports preparation of the annual audit plans, as assigned

• Assesses state of compliance with appropriate regulations and participation in the assessment of action plans to correct deficiencies.

• Provides technical and organizational leadership toward resolving site and multi‑site compliance issues.

• Alertsexecutivemanagementofsignificantquality,andcompliancerisks.

• Serves as subject matter expert on global regulated requirements and inspectional commitments, as applicable

• Provides support for domestic and international Regulatory Authority Inspections when necessary.

• Serves as senior Global Quality Compliance representative on cross‑functional teams (e.g., QMS, GPO, ALF, and special task forces) and interacts with other departments in order to achieve goals.

• Interactswithotherfunctional area leadstoensurethat
  
  Amgen
  
  Standards, strategies,anddirectionare alignedwithexistingregulationsandregulatoryexpectations.

• Provides support for audit and inspection metrics, as necessary.

• Supports Continual Improvement initiatives ,programs,and projects.

• Owns or performs QA approval for DQMS Quality Event records (Quality Incident, Deviation, CAPA, Change Control, EV for GQC and Audits & Inspections network as required).

• Experience with Aseptic Processing, Drug Product, Drug Substance, Combination Products, Data Integrity

• Certified Quality Auditor (CQA) or equivalent

• Travel:
  Domestic and International Approximately 50%

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.

• Doctorate degree and 2 years of auditor experience OR

• Master’s degree and 6 years of auditor experience OR

• Bachelor’s degree and 8 years of auditor experience OR

• Associate’s degree and 10 years of auditor experience OR

• High school diploma / GED and 12 years of auditor experience

In addition to meeting at least one of the…