Director, R&D Quality - Continuous Improvement Lead

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Director, R&D Quality - Continuous Improvement lead

LIVE

What you will do

Let’s do this! Let’s change the world! In this vital role you will be support R&D Quality by leading continuous improvement efforts focused on the Quality Management System, and you will report into the R&D Quality Leadership team. The Director, R&D Quality - Continuous Improvement Lead develops and implements a proactive, end to end, risk-based quality improvement strategy.

The Director, R&D Quality - Continuous Improvement Lead will oversee the improvement efforts for R&D Quality that are driven by signals and information about Amgen’s quality system in the form of findings, deviations, and quality trending analysis. You will be a vital part of Amgen’s Quality Management System by identifying and driving continuous improvements across R&D through the application of standard processes (Lean, DMAIC, Six Sigma).

Responsibilities

• Responsible for assessing, monitoring and continuously improving the Quality Management System processes within Amgen R&D to ensure these processes are efficient, industry leading and fit for purpose for the end user.

• Provide systematic and strategic methods to assess and measure Quality as a competitive advantage for Amgen R&D.

• Ensure People, Processes, Systems, Data Analytics and Innovation are leveraged 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 resolves issues and risks to drive clear scope, sponsorship, planning and execution.

• Lead and support management directed projects based on data driven from either Management Review or QMS trending or ad-hoc individual quality events that are of large impact/scope and thus risk for Amgen clinical trials and pre-clinical research activities.

• Set strategy, standards and performance expectations for R&D QMS Business Process Owners in Partnership RDQ Leadership Team

• Participate, conduct, lead industry collaborations aimed to advance Amgen’s QMS within R&D.

• Stay informed of evolving regulatory requirements and industry trends related to quality management systems, and proactively assess their impact on the organization.

• Provide Continuous Improvement / Root Cause Analysis expertise, exemplary leadership and facilitation skills necessary in response to improvement opportunities resulting from inspections and or audits.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The individual we seek has technological literacy and leadership skills, and has these 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 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 experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

• 15 years or more experience in Quality Management, Quality Assurance, Continuous Improvement, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality management and quality by design are a core responsibility.

• Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise.

• Thorough understanding of Clinical R&D activities and Global Regulations.

• Knowledge of the Regulatory Submission and Inspection Management procedures.

• Experience with Continuous Improvement Training and Certifications

• Upskilling research and development in DMAIC, LEAN and Sigma methodologies.