Executive Director, Quality Data Analytics and Process ManagementAmgen • Thousand Oaks, California, United States

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Executive Director, Quality Data Analytics and Process Management

Amgen

Thousand Oaks, California, United States

Thousand Oaks, California, United States

À propos

Executive Director, R&D Quality Data Analytics and Process Management – lead the strategy, governance, and continuous improvement of core quality processes, document management, enterprise data analytics, and risk management for the R&D Quality organization. Responsibilities Develop and execute a multi-year strategy for process management, data analytics, document management, and risk management aligned with R&D Quality priorities. Serve as a strategic advisor to R&D Quality leadership on process performance, clinical quality trends, operational risk, and digital opportunities. Build a high‑performing organization focused on innovation, simplification, and measurable business impact. Own core R&D Quality processes such as deviations/nonconformances, CAPA, change control, training, and risk management. Support process owners in developing 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. Lead periodic process reviews, health checks, and continuous improvement initiatives for core processes. Establish a modern analytics strategy 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 the use of automation, artificial intelligence–enabled analytics, and digital tools to improve decision‑making. Design and lead a comprehensive clinical quality analytics framework supporting risk‑based quality management and centralized monitoring across the clinical trial portfolio. 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. Qualifications Doctorate degree and 6 years of experience in pharmaceutical/biotech quality systems, clinical quality, R&D operations, analytics, or process management. Or Master’s degree and 10 years of experience in the same areas. Or Bachelor’s degree and 12 years of experience in the same areas, plus 6 years of managerial experience leading people or programs. 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, and global health authority expectations for drug development and digital processes. Proven track record in responding to health authority inspections. Benefits and Compensation Salary range: $241,844 – $327,200 (U.S.) depending on qualifications and experience. Competitive total rewards plan including health and welfare plans, retirement savings plan, life and disability insurance, flexible spending accounts, and discretionary annual bonus. Long‑term incentives: stock‑based incentives. Paid time off, bi‑annual company shutdowns, and flexible work models where possible. Career development opportunities and supportive work environment. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will provide reasonable accommodation for individuals with disabilities to participate in the application or interview process and perform essential job functions.
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Thousand Oaks, California, United States

Compétences linguistiques

English

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