Director, R&D Process Quality Business Intelligence & Data Analytics

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll 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, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Director, R&D Process Quality Business Intelligence & Data Analytics What you will do In this vital role, you will work with a team of process-focused colleagues who execute Amgen’s Process Quality strategy, ensuring that Amgen’s Research and Development Standards (SOPs and associated documentation) are adequate, clear, and compliant with current regulations and quality requirements. The Director of Business Intelligence & Data Analytics (BIDA) develops and implements a proactive, end-to-end, risk-based quality improvement strategy, focusing on the analysis of Quality System data and generating quality metrics to help Amgen’s QMS function effectively and efficiently. The R&D Process Quality team supports the Quality Management System (QMS) across all areas of research at Amgen, from discovery through the full clinical development lifecycle. This team ensures that all Amgen’s business procedures meet internal and external quality standards and are managed for optimum efficiency and effectiveness. Responsibilities Provide systematic and strategic methods to assess and measure Quality as a competitive advantage for Amgen R&D. Provide strategic leadership in developing and implementing systematic methods to measure and improve R&D quality, ensuring alignment of all data analytics and business intelligence initiatives with broader organizational goals and evolving regulatory requirements. Ensure effective use of People, Processes, Systems, Data Analytics, and Innovation to foster a proactive predict and prevent culture. Collaborate with internal R&D team members to analyze and resolve issues and risks to drive clear scope, sponsorship, planning, and execution. Lead and support data-driven projects that are of large impact/scope for Amgen clinical trials and pre-clinical research activities. Support Amgen’s procedural framework through the development, maintenance, and communication of procedural performance measures/indicators; ensure compliance with relevant laws, regulations, and internal quality standards. Ensure that all of Amgen’s research procedures are properly measured for performance and that key partners are informed regularly; support the management review system within the Amgen QMS through timely generation of reports and tracking of key actions. Support the procedural change process through communication of metrics designed in collaboration with the Business Process Owner network and leadership across R&D functional areas. Collaborate with Business Process Owners to identify and mitigate risks towards the continuous advancement of Amgen’s R&D QMS. Lead the application of process metrics (KQI, KPI) and modern analytic methods across the Business Process Network to support periodic review by management. Collaborate with other quality professionals within R&D to support the QMS continuous improvement cycle (Plan, Do, Check, Act), including Deviation Management/Corrective and Preventative Actions (CAPA). What we expect of you The individual we seek has technological literacy and leadership skills, with the following qualifications: Basic Qualifications: Doctorate degree and 4 years of quality experience OR Master’s degree and 8 years of quality experience OR Bachelor’s degree and 10 years of quality experience In addition to meeting one of the above requirements, you must have at least 4 years of experience directly managing people and leadership experience leading teams, projects, programs, or directing the allocation of resources. Preferred Qualifications: 15 years or more experience in Quality Management, Quality Assurance, Continuous Improvement, or relevant areas of the pharmaceutical/biotech industry. Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Trackwise. Thorough understanding of Clinical R&D activities and Global Regulations. Well versed in the development of quality measures in a complex, cross-functional/matrixed environment. Strong analytical capabilities - experience with process monitoring and advanced analytical methods (e.g., Spotfire, PowerBI, Python). Innovative spirit, willing to challenge the status quo. Knowledge of Regulatory Submission and Inspection Management procedures. People leadership and managerial expertise. Collaborative and flexible – able to work in ambiguity while defining motivating standards. Proven team player – takes direction, rapidly learns, and supports a hard-working team. Excellent verbal and written communication skills. Capability to understand and articulate technical concepts in spoken and written English. What you can expect of us We care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, comprising health and welfare plans, financial plans for retirement, work/life balance, and career development opportunities: A comprehensive employee benefits package, including a Retirement and Savings Plan with company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program. Stock-based long-term incentives. Award-winning time-off plans. Flexible work models, including remote and hybrid work arrangements. Apply now for a career that defies imagination Join us. careers.amgen.com In any materials you submit, you may redact age-identifying information. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we select a candidate. Amgen fosters an inclusive environment of diverse, ethical, committed, and highly accomplished people who respect each other and live the Amgen values. 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 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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