Director, GxP Learning & Performance - Process, Governance, and Metrics

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, GxP Learning & Performance - Process, Governance, and Metrics

What you will do

Let’s do this. Let’s change the world. In this vital role you will drive the Learning process optimization and improvement across Global Quality and GxP in partnership with critical stakeholders across the matrix. This will include serving as the key point of contact for GxP Learning Community of Practice (CoP) and the Training Management Processes across the Learning Ecosystem (Operations and R&D). The position will drive achievement of GxP outcomes through continuous improvement, metrics, and overall growth and transformation of the learning landscape through local SMEs and local learning leads.

• Driving change management to promote a culture of continuous improvement and embedding it into our daily work, partnering with cross functional leadership in developing and rolling out a culture of learning performance.
• Building, maintaining, and leveraging relationships across the pillars to find opportunities for process improvement, facilitate the implementation of process improvement, and continuously monitor processes and outcomes.
• Maintain global processes, procedures, and training materials in compliance with Global GxP requirements, Amgen Global Quality Standards, and Amgen’s Quality Management System (QMS) principles.
• Define Community of Practice (CoP), including roles, operating mechanisms, communication strategies, and governance of learning processes to drive continuous improvement.
• Develop and implement a risk-based learning approach for E2E processes supporting regulated functional areas across the product lifecycle.
• Provide leadership, coaching, and training for CoP including both technical processes and behaviors necessary to optimize process execution.
• Assess, analyze, and implement solutions across the Learning Ecosystem to identify and eliminate waste.
• Key partner in building capabilities and driving quality growth mindset to establish a center of excellence for Quality capability building, defining standards, deployment model, in collaboration with Quality Leadership and key learning leads.
• Optimize competency / capability-based processes to replace and/or supplement read & understood methodology
• Participate / Lead regulatory surveillance and benchmarking initiatives with peers externally to stay abreast of changes in regulations that affect impacted processes and to identify new ways of working and evolving technology in the learning space.
• Define process monitoring methods, including data collection and analysis, metrics, and associated targets, and reporting mechanisms, including both quality, operations, and R&D processes
• Support site and functions during regulatory inspections and audits, which may include direct work with inspectors/auditors and writing / reviewing responses.
• Through major initiatives (e.g. integration, divestiture, or reorganization) serve and/or lead program teams, manage interim state of operations, ensure establishment of defined future state or processes, as applicable.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a go getter with these qualifications.

Basic Qualifications:

Doctorate degree and 4 years of Operations and/or Development experience

Or

Master’s degree and 8 years of Operations and/or Development experience

Or

Bachelor’s degree and 10 years of Operations and/or Development experience

In addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experien