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. Join us.

SENIOR MANAGER, DIGITAL TECHNOLOGY & INNOVATION (DTI) – QUALITY

LIVE

WHAT YOU WILL DO

Let’s do this. Let’s change the world. In this vital role you will act as the DTI Quality leader supporting the Quality organization and will be a member of the DTI Quality Leadership Team, contributing to the strategic directions of both Quality and DTI. As a DTI leader, you are accountable for strategic technology planning/road-mapping, operational run and building of new capabilities in at least one Quality domain, supporting both Thousand Oaks, and all of Amgen’s global Operations sites.

Operations DTI (ODTI) is accountable for the delivery of technology systems that enable the successful development, design, manufacturing, distribution, and commercialization of Amgen products. ODTI is responsible for the development and execution of the DTI strategy, architecture and operations by delivering business information systems, DTI services and digital technology solutions and devices.

As a Senior Manager, you will:

Be responsible for the Digital Quality program and associated projects to enable and effective quality system. Partner in the business transformation while providing strategic leadership and drive tactical execution.

Drive strategic direction of the Quality Management Systems replacements and the EHSS technology portfolio.

Provide technical & program/project leadership to the project teams in all project phases (design, delivery, startup, commissioning, validation and operational support) as well as IS leadership oversight to ensure the program/project budget, schedule and staffing is commensurate to enabling the manufacturing automation and information systems to attain the performance standards required to support the business objectives. Influence the development of business area strategy where appropriate

Direct efforts of DTI integrators, vendors, contractors, and Amgen teams in the successful execution of efforts by using appropriate development methodologies to meet

Collaborate in the development and implementation of strategies for coordination of site installations of Amgen's corporate managed computing systems. Create collaborative relationships with groups across DTI to harmonize practices and support

Collaborate with the various DTI organizations in Amgen which are essential to the effective use of technology.

Foster a culture of agile innovation by directly overseeing the execution of proof of concepts, pilots, and projects based on cutting edge technology to help ODTI and Operations be best in class. Be a thought leader in the development of a product team structure across DTI Quality.

Monitor external technology changes and be a source of continuous innovation, facilitating speed to and in market and competitive advantage. Use technology to drive innovation in the business.

Define and execute forward-looking plans to develop and deploy relevant new technology; and work to ensure smooth adoption of those technologies and delivery of efficiencies.

Understand current best practices and emerging technologies in software applications (mobile, SaaS) security, validated/ cGMP compliant systems, infrastructure, cloud, data, advanced analytics, simulation & modeling, machine learning and artificial intelligence.

WIN

WHAT WE EXPECT OF YOU

We are all different, yet we all use our unique contributions to serve patients. The highly motivated and strategic Information Systems professional we seek has these qualifications.

BASIC QUALIFICATIONS:

Doctorate degree and 2 years of Information System experience

OR

Master’s degree and 6 years of Information System experience

OR

Bachelor's degree and 8 years of Information System experience

Or

Associate’s degree and 10 years of Information System experience

Or

High school diploma / GED and 12 years of Information System experience

And

2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

PREFERRED QUALIFICATIONS:

10+ years of Information System experience

Experience working with senior DTI and business executives

Working knowledge with the following:

Manufacturing information systems in cGMP supervised environments, FDA cGxP and 21

CFR Part 11 regulations, software development lifecycle and system validation

Enterprise business systems delivery, support, and service ownership in the areas of Manufacturing, Supply Chain, Quality, Laboratory, and Engineering

Experience in quality management in clinical and commercial manufacturing

Strong program leadership skills, including but not limited to the following: client interfacing and resolution of business partner concerns, developing and reporting results, technical mentorship, detailed planning, vendor/contract management, validation, technical solution evaluation.

Biopharma and/or Pharmaceutical experience

Ability to communicate Operations’ aspirations for demonstrating data and sophisticated analytics into the reality of detailed actions in the laboratory, manufacturing, supply chain, quality, engineering, and DTI organizations

Experienced in the delivery of projects using Agile/Scrum Methodology and ability to translate business requirements into Product Backlog for delivery

Experience resolving issues, designing strategies and implementing solutions as they pertain to global, multi system environments

Experience at developing system migration and evolution strategies and turning the strategies into plans which are implemented

Demonstration of effective coordination of business process and system issues across multiple departments and multiple functions

Adaptability, teamwork and decisiveness in rapidly changing/growing business environments

THRIVE

WHAT YOU CAN EXPECT OF US

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

Vast opportunities to learn and move up and across our global organization

Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits