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Executive Director, Quality Data Analytics and Process ManagementInitial Therapeutics, Inc. • Thousand Oaks, California, United States
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Executive Director, Quality Data Analytics and Process Management

Initial Therapeutics, Inc.
  • US
    Thousand Oaks, California, United States
  • US
    Thousand Oaks, California, United States
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À propos

Executive Director, R&D Quality Data Analytics & Process Management 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.
A critical component of the role is advancing clinical and research quality analytics across the development portfolio to enable proactive oversight of clinical trials, investigator sites, vendors, and study execution risks. This leader will transform data into actionable insights that strengthen Good Clinical Practice (GCP) compliance, inspection readiness, patient safety, and study quality.
The role is accountable for oversight of document management systems and governance, quality process harmonization, advanced analytics, KPI reporting, and R&D risk management across the R&D GxP areas including clinical development, pharmacovigilance, laboratories, and R&D quality systems.
This position partners closely with R&D Quality leadership, Global Quality, Global Development Operations, Data Management, Biostatistics, Safety, Regulatory Affairs, and technology functions to strengthen compliance, decision-making, and operational performance. This role will report into Vice President, Quality.
Responsibilities Strategic Leadership
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.
Document and Process Management
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.
Quality Data Analytics & Data-Driven Insights
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.
Talent & Organizational Capability
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.
What we expect of you We are all different, yet we all use our unique contributions to serve patients. The executive candidate we seek is an experienced leader with the following qualifications.
Basic Qualifications
Doctorate degree and 6 years of pharmaceutical/biotech quality systems, clinical quality, R&D operations, analytics, or process management OR
Masters degree and 10 years of pharmaceutical/biotech quality systems, clinical quality, R&D operations, analytics, or process management OR
Bachelors degree and 12 pharmaceutical/biotech quality systems, clinical quality, R&D operations, analytics, or process management AND
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
Preferred Qualifications
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, guidances 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
They will also embody the Amgen leadership attributes which are:
Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thrive
Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection
Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders
Adapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results
What you can expect of us As we work to develop treatments that take care of others, we also care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $241,844 - $327,200. Actual salary will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
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. Refer to the Work Location Type in the job posting to see if this applies.
Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
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 ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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  • Thousand Oaks, California, United States

Compétences linguistiques

  • English
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