GxP Quality Operating Model Process Lead- US Remote

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.

GxP Quality Operating Model (QOM) Process Lead

What you will do

Let’s do this. Let’s change the world. GxP Quality Operating Model (QOM) Process Lead, you will support the development, implementation, and sustainability of the GxP Quality Operating Model (QOM) with a focus on governance, process architecture, and cross-functional collaborator management. This position will be classified as a remote position and will report to the Senior Director, GxP Quality.

This role will require a deep understanding of R&D and Operations strategy to design and optimize the GxP Process Architecture within the GxP Quality Operating Model. By integrating end-to-end processes under global process owners, this role will drive performance improvements, enhance efficiency, and ensure alignment with business needs and priorities.

To achieve this objective, the role partners closely with 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 role also collaborates with Global QMS leaders external to Amgen in benchmarking and continuous improvement.

Responsibilities:

• Support the development and execution of a GxP Quality Operating Model (QOM) governance forum with cross-functional representation, ensuring the long-term sustainability of the QOM
• Support the development, maintenance, and continuous improvement of an integrated GxP process architecture to account for all end-to-end processes required to facilitate a drug or biologic across development, through registration and into full commercialization
• Manage the approval and integration of the GxP process architecture across collaborators; review and be responsible for required revisions to process and document architecture based on internal and regulatory changes
• Collaborating across Global Quality, define the role of the global process owner (GPO), considering the new capabilities required to drive improvement in processes across GxPs vs those processes whose scope is in within one domain of GxP (e.g., GMP)
• Lead the organizational design around a GxP GPO function, including management of JDs / capabilities, the implementation and leadership of an integrated GxP GPO forum / network supporting both Operations and R&D, and dedicated process support for cross-functional GxP GPOs
• Define and implement single source of truth GxP critical metrics focused on the health of the quality system, Quality risk, resourcing, and value measured through continuous improvement and major Quality initiatives
• Develop and maintain the new GxP Quality Manual, ensuring alignment with evolving regulatory expectations, and provide recommendations on objectives to be included in the Level 0 Quality Plan
• Drive training initiatives to support the awareness, understanding, and adoption of the GxP QOM across the enterprise
• Additional leadership and support opportunities to be defined as the GxP QOM transitions into full implementation

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Process Lead we seek is an experienced leader with the following qualifications. They will also embody the Amgen leadership attributes which are:

• Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thrive
• Accelerate: Enable speed that matches the vitality of patient needs by encouraging progress over perfection
• Integrate: Connect the dots to amplify the collective power of Amgen to get results for patients, staff, and shareholders
• Adapt: Lead through change by adapting