GxP Quality Operating Model Process Lead- US Remote

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 youll 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 awardwinning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll 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

Lets do this. Lets 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 crossfunctional 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 endtoend 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 of a GxP Quality Operating Model (QOM) governance forum with crossfunctional representation ensuring the longterm sustainability of the QOM
• Support the development maintenance and continuous improvement of an integrated GxP process architecture to account for all endtoend 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 crossfunctional 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 to a constantly evolving environment and defining a clear course of action to deliver results

Basic Qualifications:

Doctorate degree and 3 years of R&D Operations and/or Quality experience in the PhRMA/Biotech sector

Or

Masters degree and 5 years of R&D Operations and/or Quality experience in the PhRMA/Biotech sector

Or

Bachelors degree and 7 years of R&D Operations and/or Quality experience in the PhRMA/Biotech sector

Or

Associates 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

Preferred Qualifications:

• 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 largescale 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

What you can expect of us

As we work to develop treatments that take care of others we also work to care for your professional and personal growth and wellbeing. From our competitive benefits to our collaborative culture well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $158802 to $185174 Actual salary will vary based on several factors including but not limited to relevant skills experience and qualifications.

In addition to the base salary Amgen offers a Total Rewards Plan based on eligibility comprising of health and welfare plans for staff and eligible dependents financial plans with opportunities to save towards retirement or other goals work/life balance and career development opportunities that may include:

• 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 salesbased incentive plan
• Stockbased longterm incentives
• Awardwinning timeoff plans
• Flexible work models including remote and hybrid work arrangements where possible

Apply now and make a lasting impact with the Amgen team.

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Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

As an organization dedicated to improving the quality of life for people around the world Amgen fosters an inclusive environment of diverse ethical committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability status or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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