R&D Quality Assurance Strategic Performance and Operations Director

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.

R&D Quality Assurance Strategic Performance and Operations Director

Live

What you will do

Let’s do this! Let’s change the world!

This leadership role in Research and Development Quality Assurance (RDQ) supports Research & Development and the Office of the Chief Medical Office and Regulatory Affairs serving as a member of the RDQ leadership Team, reporting to the Vice President (VP) of RDQ. The Director of RDQ Strategic Performance and Operations is responsible for managing the day to day operations of supporting our growing team including: supporting and helping drive RDQ transformation and advancement including: ways of working, build of quality analytics, advancing risk assessments, quality metric trending and driving performance management. Additionally, driving organization of key RDQ meetings including RDQ Leadership, All Staff and Group Meetings. Driving/tracking progress of continuous improvement and process simplification and optimization, digital, data structure build & analytics and technology processes and solutions. Candidates must possess experience in effective decision making, influencing skills, and ability to simultaneously manage numerous complex issues and projects. This position requires demonstration of strong management and leadership skills along with advanced communication and analytical skills.

Key areas of responsibility:

Change the Business - strategy and initiatives:

• Partner with RDQ LT to agree to priorities, quantitate opportunities that support the overall RDQ and Global Quality strategies

• Develop the concept for change and advancement to a deployable strategy – identifying and quantitating opportunities to simplifying processes, removing non-value added activities and drive value for Amgen

Transformation and Continuous Improvement:

• Working with RDQ LT and their direct reports to drive and track RDQ transformation and continued advancement (people process and technology)

• Support the build of new ways of working tools that drive/advance simplicity, connectivity and insights that are scalable to the business needs

• Support new technology development

Risk management/work prioritization:

• Support build and drive of risk assessment and risk prioritization of RDQ work, supporting effectively the management of resources, driving what we spend time on and what we do not

• Drive provisional status decision making process as it relates to RDQ people, processes, technologies

Chief of Staff:

• Ensure on time delivery of any action items and commitments

• Develop advance and implement RDQ communication strategy

• Build VP and appropriate RDQ LT presentations

• Responsible for regular RDQ LT meetings. This includes coordinating agenda topics, consolidating presentation and pre-read content, distributing pre-reads, facilitating each meeting, and creating/distributing minutes and follow up on action items

• Partner with HR Business Partner to support talent management meetings, staffing/organizational initiatives as deemed necessary, and organizational or workforce strategy related efforts

• Partner with RDQ, finance lead to educate on and translate functional priorities and business details related to financials. Partner on data and visualization appropriate for audience and oversight of organizational shape and budget. Review financials monthly with leadership team

• Responsible for planning, developing, and maintaining the RDQ budget

• Coordination and oversight of organizational deliverables, annual goals, and management of the overall RDQ initiatives

• Build strong relationships with RDQ Customers

Management Reviews, Trending and QS and Quality Performance:

• Work with RDQ to monitor the key quality performance and key quality indicators for the organization.

• Where quality KPI performance is not meeting targets, support the ES/ESQ teams to develop a plan for improvement of the metric with the key partners involved.

Leadership responsibilities:

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