Senior Manager, In-Vitro Diagnostics/Precision Medicine Quality

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

SENIOR MANAGER, IN-VITRO DIAGNOSTICS/ PRECISION MEDICINE QUALITY

What you will do

Lets do this! Lets change the world! In this vital role you will report to the Senior Director, In-Vitro Diagnostics (IVD) and Precision Medicine Quality. The Senior Manager, In-Vitro Diagnostics/ Precision Medicine Quality supports the use of In-Vitro Diagnostics (IVD), including Companion Diagnostics (CdX), and Precision Medicine applications to clinical development. This role is responsible for supporting the implementation of an end to end, proactive and risk-based Quality Assurance strategy for IVD, and Precision Medicine, including third-party collaborations.

The In-Vitro Diagnostics/ Precision Medicine Quality strategy is focused on all aspects of research and development at Amgen, spanning from discovery through the entire lifecycle of clinical development. This strategy will ensure that all Amgens business procedures meet internal and external quality standards, and that they are managed for optimum efficiency and effectiveness. The In-Vitro Diagnostics/ Precision Medicine Quality strategy also ensures that the business develops and manages fit for purpose standards (SOPs and quality agreements). In addition, the strategy will ensure that Amgens QMS is continuously improved upon using quality by design, risk assessments, and outputs from the Quality Management System, including analytics showing quality trends and potential continuous improvement opportunities.

• Develop collaborative partnerships with Research and Development (R&D) to help establish the state of quality and potential areas of quality risk exposure. Contributes to the use of innovative methods for improving the quality oversight for Amgens IVD and Precision Medicine programs.

• Collaborate with colleagues in a cross-matrixed environment and ensure that Amgens R&D efforts, including partnerships and third parties, are aligned to industry best practices and all regulations.

• Support the implementation of IVD quality management strategies to ensure compliance to an evolving and complex IVD regulatory landscape, particularly in the European Union.

• Leverages metrics (KQI, KPI leading and lagging) related to IVD and Precision Medicine for Quality Management System performance and improvement.

• Collaborate with clinical trial teams to ensure that all respective critical to quality components are incorporated into clinical trial design, execution, and support of regulatory filings.

• Maintain up-to-date knowledge of IVD regulations and applicable guidance; monitor development of regulations and communicate impact to the business.

• Provides risk-based quality assurance and oversight for IVD/ Precision Medicine activities (e.g., auditing, deviation management and inspection management).

• Ensures that all applicable integrated procedures (e.g., acquired assets) are fit for purpose and aligned to Amgens standards.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The individual we seek has technological literacy and leadership skills, and has these qualifications.

Doctorate degree and 2 years of quality management experience OR

Masters degree and 6 years of quality management experience OR

Bachelors degree and 8 years of quality management experience OR

Associates degree and 10 years of quality management experience OR

High school diploma / GED and 12 years of quality management experience

• At least 3 years of experience in the pharmaceutical/biotech or medical device industry working within quality a quality management system role, or other relevant experience in clinical research that includes quality oversight (e.g., deviation management/CAPA, audit conduct, or inspection support.

• An understanding of medical device development and applicable Global Regulations.

• An understanding of Precision Medicine and applicable Global Regulations.

• An understanding of Quality Management Systems (QMS), including electronic QMS such as Veeva or TrackWise (Sparta Systems).

• Experience preferred working within research and development of In-vitro Diagnostics.

• Implementation of technology to improve knowledge management across a diverse R&D environment.

• Experience with compliance to GxP requirements including the oversight of third-party vendors, suppliers, and partners.

• Ability to incorporate business and customer feedback into clear, efficient processes using a straightforward language and format.

• Strong analytical, critical-thinking, and decision-making abilities, including development and implementation of Analytics methods and technology in order to enable signal detection and quality improvement.

• Innovative thinking, including the application of quality by design principles

• Collaborative worker with an ability to support a high performing team.

• Excellent verbal and written communication skills, including strong business writing abilities and active listening.

What you can expect of us

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

Amgen offers a Total Rewards Plan comprising 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 including:

• 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 and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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.