GxP Quality Operating Model Process Lead @1001 Amgen Inc.

[Hiring] GxP Quality Operating Model Process Lead @1001 Amgen Inc.

Mar 29, 2025 - 1001 Amgen Inc. is hiring a remote GxP Quality Operating Model Process Lead. 💸 Salary: $158,802 to $185,174. 📍Location: USA.

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Role Description

As a 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.

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

Qualifications

Doctorate degree and 3 years of R&D, Operations and/or Quality experience in the PhRMA/Biotech sector
Or Master’s degree and 5 years of R&D, Operations and/or Quality experience in the PhRMA/Biotech sector
Or Bachelor’s degree and 7 years of R&D, Operations and/or Quality experience in the PhRMA/Biotech sector
Or Associate’s degree and 12 years of R&D, Operations and/or Quality experience in the PhRMA/Biotech sector
Or High school diploma / GED and 14 years of R&D, Operations and/or Quality experience in the PhRMA/Biotech sector

Requirements

Understanding and application of operations across R&D and Manufacturing, inclusive of QMS experience in this space
Experience supporting collaborators across various GxP Quality domains (i.e. beyond GMP)
Demonstrated success in leading large-scale or complex initiatives requiring alignment and agreement from senior leadership
Must possess strong strategic savvy and exceptional persuasive communication skills to effectively drive organizational initiatives
Ability to operate independently in a strategic and tactical manner and ability to work through ambiguity across GxP in designing and implementing the QOM
Understanding of the legal and regulatory environment affecting PhRMA/Biotech
Experience fostering an environment that drives creativity and innovation
Outstanding oral and written communication and writing skills

Benefits

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible

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📍	Be aware of the location restriction for this remote position: USA
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GxP Quality Operating Model Process Lead @1001 Amgen Inc.

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Salary 💸 $158,802 to $185,174	Remote Location USA
Job Type full-time	Posted Mar 29, 2025

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📍	Be aware of the location restriction for this remote position: USA
‼	Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.

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[Hiring] GxP Quality Operating Model Process Lead @1001 Amgen Inc.

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