Director, Small Molecule Process Development

The Quality Compliance Manager at Amgen plays a crucial role in the Continuous Improvement & Innovation team within the R&D Quality Organization. This global position involves supporting processes and initiatives focused on continuous improvement and change management. As the Quality Compliance Manager, you will contribute to Amgen's Quality Management System by developing and managing R&D controlled processes aimed at continuous enhancement through the application of standard methodologies such as Lean, DMAIC, and Six Sigma. In this role, you will collaborate with Business Process Owners globally to ensure compliance with regulations and other requirements while supporting the digital quality management system (DQMS) as a subject matter expert. Your responsibilities will include designing, implementing, and supporting proactive quality improvement strategies for R&D and OCMO through established methodologies like Lean, Six Sigma, Kaizen, and more. You will supervise improvement initiatives for R&D Quality based on insights from Amgen's quality system, audits, deviations, and trend analyses. Your role will also involve leading Organizational Change Management (OCM) initiatives for projects within R&D Quality, providing expertise on continuous improvement methodologies, assisting in OCM strategies, and offering guidance to R&D functions and business process owners to ensure well-managed organizational changes. Additionally, you will collaborate with various stakeholders to implement effective communication strategies, training programs, and data analysis using tools like Excel and Smartsheet. To excel in this position, you should possess a Master's degree with 4-6 years of Pharma and Biotech R&D or commercial manufacturing Quality experience. Continuous Improvement/Change Management experience is preferred. Alternatively, a Bachelor's degree and 6-8 years of relevant experience can be considered. Essential skills include exceptional attention to detail, independent and proactive work ethic, proficiency in tools like Smartsheet and Microsoft Office Suite, and good communication skills. Familiarity with project management tools, GCP, GLP, or GPvP, and experience in a multinational environment with global teams are considered advantageous. At Amgen, we are committed to fostering an inclusive environment that values diversity, ethics, and collaboration among highly accomplished individuals. We provide reasonable accommodations for individuals with disabilities during the application process, essential job functions, and other employment benefits. Join us in advancing science to serve patients and contribute to making a lasting impact with the Amgen team.,