AI-Driven Global GMP/GDP Audit & Predictive Compliance Leader

BioSpace; Washington (District of Columbia); Presencial; USD 260.000 - 420.000; Tempo integral

Benefícios oferecidos por esta vaga

Retirement and Savings Plan

Medical/dental/vision coverage

Stock-based incentives

Flexible time-off programs

Flexible work models

Resumo da vaga

Amgen seeks a Senior Director to lead the global GMP/GDP audit and predictive compliance intelligence capability. You will shape the strategy, oversee internal audits of manufacturing sites, suppliers, laboratories, and contract organizations while guiding AI-enabled risk insights to prioritize remediation and improvement.

The role partners with RRIR, ILM, External Affairs, and senior leadership to deliver inspection readiness, proactive risk mitigation, and continuous improvement in quality and

Qualificações

• Advanced degree in a life sciences or related field with regulatory expertise.
• Evidence of leading large-scale audit and risk-management programs.
• Experience in applying analytics/AI to compliance and risk management.

Responsabilidades

• Lead the global GMP/GDP audit organization and predictive compliance intelligence capability.
• Establish strategic direction, operating model, and multiyear roadmap for both capabilities.
• Oversee global risk-based GMP/GDP audit strategy and master audit schedule.
• Ensure audit program depth across manufacturing, labs, suppliers, and distribution.
• Develop predictive models, dashboards, and early warning indicators for audit priorities.

Conhecimentos

Biologics manufacturing

Regulatory compliance

Auditing

Leadership

Analytics

Formação

Doctorate degree

Master's degree

Bachelor's degree

Descrição da vaga

Amgen seeks a Senior Director to lead the global GMP/GDP audit and predictive compliance intelligence capability. You will shape the strategy, oversee internal audits of manufacturing sites, suppliers, laboratories, and contract organizations while guiding AI-enabled risk insights to prioritize remediation and improvement.

The role partners with RRIR, ILM, External Affairs, and senior leadership to deliver inspection readiness, proactive risk mitigation, and continuous improvement in quality and