Quality Compliance Senior Manager

.Quality Compliance Senior Manager Apply remote type Remote locations United States - Remote United Kingdom - Remote Portugal - Remote time type Full time posted on Posted 18 Days Ago job requisition id R-200401 Career Category Quality 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. Senior Manager, Quality & Compliance What you will do Let's do this. Let's change the world. In this vital role, you will report to the Therapeutic Area Quality Lead - Clinical Quality, Clinical & Research Quality (CRQ). As the Senior Manager, Quality & Compliance, you will play a crucial part in our mission, providing proactive end-to-end quality support for developing and implementing a risk-based quality assurance strategy for the clinical development program. The R&D Process Quality team supports the Quality Management System (QMS) across all Amgen research areas, including discovery through the 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, including QMS analytics showing quality signals and trends. Responsibilities Create and maintain data tools to enable stakeholders to ensure quality in the R&D space. Maintain Quality oversight related to continuous improvements (CI) associated with our QMS through metrics and key performance indicators (KPIs). Supports the application of process metrics (KQI, KPI - leading and lagging) and modern analytic methods across the Business Process Network to enable Management Reviews (periodic review by management to ensure QMS health is maintained). Ensures our CI efforts maintain a quality culture throughout the R & D and GDO organizations