Global Patient Safety Business Excellence, Senior Manager

If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Join us.

In this vital role, you will drive business excellence initiatives across Global Patient Safety (GPS), providing leadership in project management, organizational change management, governance, compliance oversight, and operational effectiveness. You will partner across GPS and key cross-functional stakeholders to enable successful delivery of business-critical initiatives, strengthen inspection readiness, and advance a culture of continuous improvement.

• Lead the development, implementation, and continuous improvement of project management and change management standards, methodologies, and best practices across GPS.
• Drive and sustain GPS governance frameworks, ensuring effective oversight, decision-making, and alignment with organizational objectives.
• Lead and deliver business-critical initiatives within Global Patient Safety and represent GPS on enterprise-wide cross-functional programs.
• Provide strategic leadership and oversight for pharmacovigilance activities related to mergers, acquisitions, licensing agreements, and divestitures.
• Contribute to the advancement and effectiveness of the GPS Quality Management System, ensuring compliance with global regulatory requirements.
• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• Support Health Authority Inspection, Business Partner audits and Internal Process Audits within the remit of role and responsibility, including logistics and operational support
• Develop, monitor, and report key performance and compliance metrics to support management review, strategic decision-making, and continuous improvement.
• Facilitate cross-functional management of deviations, CAPAs, and quality improvement initiatives to ensure sustainable compliance outcomes.
• Build and maintain strong partnerships with internal and external stakeholders, influencing decisions and driving alignment across complex organizational initiatives.
• Champion digital transformation opportunities, including the adoption of automation, analytics, and emerging technologies to enhance Global Patient Safety.

We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:

• Degree educated and previous Safety Project Management experience
• Proven expertise in project and change management, organizational transformation, governance, and delivery of complex enterprise-wide initiatives.
• Significant experience in pharmacovigilance, drug safety, regulatory affairs, quality, or related life sciences functions, with strong understanding of regulatory and compliance requirements.
• Strong leadership and influencing skills, with experience working across global, cross-functional and remote teams and engaging senior stakeholders
• Demonstrated ability to manage multiple priorities, navigate ambiguity, think critically, and translate complex information and data into clear, actionable recommendations.
• Experience leveraging digital technologies, automation, data insights, and continuous improvement methodologies such as Lean, Six Sigma or Agile.
• Experience with major regulatory/safety projects and life sciences…