Executive Director, Quality Data Analytics and Process Management

Amgen • Thousand Oaks, CA

4d • $241,844 - $327,200

About The Position

Join Amgen’s Mission of Serving Patients. Amgen is a leader in biotechnology, focused on pioneering treatments for serious illnesses in Oncology, Inflammation, General Medicine, and Rare Disease. This role is vital for leading 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. The leader will be the business process owner for key Quality Management System (QMS) processes, ensuring efficiency, compliance, scalability, and alignment with regulatory expectations. A key aspect is advancing clinical and research quality analytics to enable proactive oversight of clinical trials, investigator sites, vendors, and study execution risks. This role transforms data into actionable insights to strengthen Good Clinical Practice (GCP) compliance, inspection readiness, patient safety, and study quality. The position oversees document management systems, quality process harmonization, advanced analytics, KPI reporting, and R&D risk management across R&D GxP areas. It partners closely with R&D Quality leadership, Global Quality, Global Development Operations, Data Management, Biostatistics, Safety, Regulatory Affairs, and technology functions to enhance compliance, decision-making, and operational performance. This position reports into the Vice President, Quality.

Requirements

• Doctorate degree and 6 years of pharmaceutical/biotech quality systems, clinical quality, R&D operations, analytics, or process management OR Master’s degree and 10 years of pharmaceutical/biotech quality systems, clinical quality, R&D operations, analytics, or process management OR 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 Haves

• 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

Responsibilities

• 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 deliver 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree