This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
Join Amgen’s Mission of Serving Patients. In this vital role you will be responsible for implementing Global Quality Compliance Audits and assigned tasks and/or projects necessary to achieve corporate and departmental goals.
Job Responsibility:
Coordinates, leads, or participates in Corporate Quality Compliance Audits of Corporate Quality Management System, Amgen sites, Contract facilities, Affiliates, and Critical Service providers
Assesses state of compliance with appropriate regulations and lead or participates in the assessment of action plans to correct deficiencies
Implements risk assessments
Ensure completion, maintenance and sustainability of the assigned training per specific roles to support the audit process
Provides leadership toward calling out site and multi-site compliance issues resulting from audit findings
Serves as subject matter expert on global regulated requirements and inspectional commitments
Provides support for domestic and international Regulatory Authority Inspections when necessary
Provides technical support/compliance review of multi-site/global documents resolving compliance issues
Interacts with other functional leads to ensure that Amgen Standards, strategies and direction are aligned with existing regulations and regulatory expectations
Alerts senior and/or executive management of significant quality, and compliance risks
Provides support for audit and inspection metrics as vital
Supports Continual Improvement initiatives, programs and projects
Requirements:
Master’s degree
12 to 15 years in Pharmaceutical and/or Biotechnology in Quality and/or Manufacturing experience
Lead Auditor Certification
Audit Experience in Drug Substance (DS), Drug Product (DP), Finished Drug Product (FDP), Medical Device, Combination Product, and/or Active Pharmaceutical Ingredients (API)
Strong communication skills both verbal and written
Domestic and International travel up to 50%
Nice to have:
Lead Auditor Certification
Audit Experience in Drug Substance (DS), Drug Product (DP), Finished Drug Product (FDP), Medical Device, Combination Product, and/or Active Pharmaceutical Ingredients (API)
Strong communication skills both verbal and written
What we offer:
competitive and comprehensive Total Rewards Plans that are aligned with local industry standards