Executive Director, Quality Data Analytics and Process Management

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer heart disease inflammatory conditions rare diseases and obesity-related conditions.

As a member of the Amgen team youll help make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives.

Our award-winning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Executive Director R&D Quality Data Analytics and Process Management

What you will do

Lets do this. Lets change the 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 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.

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 work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $241844 - $327200. 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.

As an organization dedicated to improving the quality of life for people around the world 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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