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

Career Category

Job Description

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

Let’s do this! Let’s change the world! In this vital role you will work with a team of process-focused colleagues who work to execute Amgen’s Process Quality strategy, which is vital to ensuring that Amgen’s Research and Development Standards (SOPs and associated documentation) are adequate, clear, and up to all applicable 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 the generation of quality metrics to help Amgen’s QMS function effectively and efficiently, while improving continuously as driven by the quality data.

The R&D Process Quality team supports the Quality Management System (QMS) across all areas of research at Amgen, including 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. The Process Quality team also ensures that Amgen’s R&D Business Process Network develops and manages fit for purpose standards (SOPs) that are continuously improved upon using quality by design (QbD), and risk management methods that include QMS analytics showing quality signals and trends.

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 People, Processes, Systems, Data Analytics and Innovation are used effectively to move Quality Culture towards a proactive predict and prevent culture.

• Effectively lead, collaborate and partner with internal R&D team members to analyze and resolve issues and risks to drive clear scope, sponsorship, planning and execution.

• Lead and support management directed data driven projects that are of large impact/scope and thus risk 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 that all procedures maintain compliance to relevant laws, regulations, and internal quality standards; so that Amgen treats all research subjects ethically and safely, and all data is generated with full integrity.

• Ensure that all of Amgen’s research procedures are properly measured for performance and that key partners, including management, are informed regularly; work to 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 the communication of metrics designed in collaboration with the Business Process Owner network and leadership across R&D functional areas.

• Collaborate with Business Process Owners and apply risk-based strategies consistently to identify and mitigate risks towards the continuous advancement of Amgen’s R&D QMS.

• Lead the application of process metrics (KQI, KPI - leading and lagging) and modern analytic methods across the Business Process Network to support periodic review by management to ensure maintenance of QMS health.

• Collaborate with other quality professionals within R&D to support the QMS continuous improvement cycle (Plan, Do, Check, Act), including Deviatio