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Amgen Logo Amgen · Quality Control

Executive Director, Quality Data Analytics and Process Management

United States, Thousand Oaks Employment contract 241843.70 - 327200.30 USD / Year · Job Posted May 29, 2026
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Job Description

In this vital role as the Executive Director, R&D Quality Data Analytics & Process Management, you will lead the strategy, governance, and continuous improvement of core quality processes, document management, enterprise data analytics, and risk management for the Research & Development (R&D) Quality organization. This leader will serve as the business process owner for key Quality Management System (QMS) processes supporting global R&D operations and ensure processes are efficient, compliant, scalable, and aligned with evolving regulatory expectations.

Job Responsibility

  • Develop and execute a multi-year strategy for process management, data analytics, document management, and risk management aligned to R&D Quality priorities
  • Serve as a strategic advisor to the Head of R&D Quality on process performance, clinical quality trends, operational risk, and digital opportunities
  • Build a high-performing organization focused on innovation, simplification, and measurable business impact
  • Act as business process owner for core R&D Quality processes such as deviations/nonconformances, CAPA, change control, training (metrics) and risk management
  • Support the R&D business process owners to develop global standards, process controls, KPIs, roles/responsibilities, and governance for assigned processes
  • Ensure simplification, standardization, and modernization of document structures and approval workflows in partnership with Global Quality
  • Ensure processes are compliant with applicable GxP regulations and integrated across functional boundaries
  • Lead periodic process reviews, health checks, and continuous improvement initiatives related to these processes
  • Establish a modern analytics strategy for R&D Quality using dashboards, predictive indicators, trend analysis, and self-service reporting tools
  • Develop executive dashboards for quality performance, compliance health, process efficiency, inspection readiness, and risk visibility
  • Champion use of automation, AI-enabled analytics, and digital tools to improve decision-making
  • Develop and lead a comprehensive clinical quality analytics framework supporting risk-based quality management and centralized monitoring across the clinical trial portfolio
  • Identify cross-study and portfolio-level trends that may indicate systemic GCP risks or process weaknesses in partnership with Clinical & Research Quality
  • Integrate risk signals from audits, inspections, deviations, vendors, metrics, and operational changes to delivery comprehensive insights
  • Partner with Clinical Delivery and Study Quality teams to integrate quality signals into ongoing study oversight and risk review forums
  • Use predictive analytics to identify trials, countries, vendors, or sites at increased risk for quality or inspection issues
  • Support inspection readiness through analytics related to TMF completeness, overdue actions, protocol compliance, training status, and vendor oversight performance
  • Develop executive reporting on clinical quality health across Phase I-IV programs, CRO partnerships, and development regions
  • Benchmark internal metrics against industry trends and regulatory expectations where available
  • Build and develop teams across process excellence, analytics, document management, and risk management disciplines
  • Develop organizational capability in process thinking, data literacy, and risk-based decision making
  • Foster a culture of accountability, innovation, and continuous learning

Requirements

  • Doctorate degree and 6 years of pharmaceutical/biotech quality systems, clinical quality, R&D operations, analytics, or process management
  • Master's degree and 10 years of pharmaceutical/biotech quality systems, clinical quality, R&D operations, analytics, or process management
  • Bachelor's degree and 12 years of pharmaceutical/biotech quality systems, clinical quality, R&D operations, analytics, or process management
  • 6 years of managerial experience directly leading people in a multi-tiered organization and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Nice to have

  • Strong knowledge of GCP, GxP regulations, ICH E6, risk-based quality management, and quality management systems
  • Demonstrated success leading analytics, digital transformation, or complex process improvement programs
  • Understanding of the legal and regulatory environment, applicable laws, regulations, guidance's and health authority expectations globally for drug development and digital processes and Artificial Intelligence
  • Proven track record in management and subsequent response to health authority inspections

What we offer

  • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans and bi-annual company-wide shutdowns
  • Flexible work models where possible
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