Senior Director, GxP Quality

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.

Senior Director, GxP Quality

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What you will do

Let’s do this! Let’s change the world! In this vital role as the Senior Director, you will lead the development and execution of a Global, Enterprise-wide strategy for the Amgen GxP Quality Management Operating Model. This position will be classified as a remote position and will report to the Vice President, Quality Operating Systems, Services and Sciences.

In this position, the candidate will collaborate across R&D, Operations and Commercial in defining and integrating the elements of the operating model inclusive of Process Excellence, Digital, People/Culture and Operational Excellence. As part of this the incumbent will also be responsible for developing GxP strategy required to integrate other companies associated with mergers and acquisitions.

The role will need to ensure deep understanding of the R&D, Operations and Commercial strategy in order to enhance the competitive advantage of the GxP Quality Management Operating System (QMOS) to drive performance improvements in alignment with business needs and priorities.

To achieve this objective, the position partners closely with Senior Leadership across R&D and Operations (Discovery Research, Translational Sciences, Global Regulatory Affairs and Safety, Global Development, Global Medical Affairs, and Manufacturing, Supply Chain, Product Development, Central Strategy Functions, Compliance, and Audit). The position also collaborates with Global QMS leaders external to Amgen in benchmarking and continuous improvement.

Responsibilities:

• Lead a team of professional staff in the range of 5 to 15 individuals.
• Design and integrate the Quality Management Systems into a modern GxP Quality Management Operating System across each of the four elements as defined above.
• Define process excellence and an integrated process architecture to account for all of the end-to-end processes required to facilitate a drug or biologic across development, through registration and into full commercialization.
• A second key aspect of process excellence will require assessing the document management maturity and defining a new vision for a GxP document landscape ensuring it is effective and simplified.
• For the Digital element of the QMS, this role will partner with the Global Quality Digital group that supports development and execution of the GQ Digital strategy.
• For the People/Culture element of QMOS, redefine the role of the process owner considering the new capabilities required to drive improvement in processes across GxP vs those processes whose scope is in within one domain of GxP (e.g., GMP).
• Work with HR and business functions, to assess and appoint process owners according to the evolved maturity required to drive transformation change.
• Manage a GxP Document Management Process Owner that will be responsible for the document hierarchy across GxP including all associated templates.
• For the Operational Excellence element of QMOS, define and implement process health metrics designed to monitor the overall health and risk of the QMOS including all associated return on investment related to the Quality process and digital architecture.
• Manage a GxP Management Review process owner whose role will be to handle this process including collaborating across functions in the design and implementation. This role will also lead the future development of the Quality Management Maturity Model as regulatory guidance evolves in this area.
• Serve as the integration lead for designing and executing M&A strategy relative to the QMOM. Design and implement process risk assessments required to determine areas of opportunity relative to process improvement across GxP. Represent Quality on cross-functional integration office forums.
• Play a lead role in presenting the Amgen QMOS external health authorities during regulatory inspections and audits. Ensures that effective processes are in place to keep the QMS in a state of compliance with external, global regulatory requirements across GxP.
• Participates in Industry forums designed to benchmark and continuously improve in the areas of Quality Management.

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What we expect of you

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