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.
Senior Manager, In-Vitro Diagnostics/ Companion Diagnostics/ Precision Medicine Quality
What you will do
Let’s do this! Let’s change the world! In this remote role you will report to the Director of Precision Medicine and Diagnostics within R&D Quality. This role supports the use of
In-Vitro Diagnostics (IVD), including Companion Diagnostics (CDx), within Amgen’s global clinical trials. This role is responsible for supporting the implementation of a proactive and risk-based Quality strategy for IVD medical devices, including collaborations with diagnostic partners (testing laboratories).
The Precision Medicine and Diagnostic Quality strategy is focused on all aspects of research and development at Amgen, spanning from discovery through the entire lifecycle of clinical development.
Responsibilities
Support quality oversight of IVD medical devices used within Amgen’s precision medicine and digital medicine clinical trials.
Provide subject matter expertise on the regulatory and quality oversight of
IVDs, including CDx, Laboratory Developed Test (LDTs), assays, within the areas of precision and digital medicine.
Collaborate with Amgen’s IVD and diagnostic partners to ensure quality oversight of IVDs/ assays used within Amgen drug clinical trials to ensure industry standard processes and all regulations are followed.
Supports the IVD/ CDx team and collaborators to ensure that IVD/ CDx quality management strategies are advanced related to the evolving and complex IVD regulatory landscape, including the EU and US.
Provide support for Quality Agreements, clinical trial protocol review, Informed Consent form reviews, IRB application review.
Provide support for EU Clinical Performance Studies and US IDE requirement implementation.
Understands and contributes to the collection and use of metrics (KQI, KPI leading and lagging) related to IVD and Precision Medicine for Quality Management System performance and improvement.
Maintains 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 Amgen’s standards.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of quality, regulatory, or Companion Diagnostic experience OR
Master’s degree and 4 years of quality, regulatory, or Companion Diagnostic experience OR
Bachelor’s degree and 6 years of quality, regulatory, or Companion Diagnostic experience OR
Associate’s degree and 10 years of quality, regulatory, or Companion Diagnostic experience OR
High school diploma / GED and 12 years of quality, regulatory, or Companion Diagnostic experience
Preferred Qualifications:
Experience within the pharmaceutical/ biotech, medical device, and/or biomarker industry working with In-Vitro Diagnostics (IVD) and preferably Companion Diagnostic (CDx) devices.
Experience working with Companion Diagnostics/ assay development for the pharmaceutical industry/ CLIA cert and/or ISO 15189 cert labs/ biomarker testing.
Experience working in a quality management system role, or other relevant experience in a clinical research environment that includes quality oversight (e.g., deviation management/CAPA, audit conduct, or inspection support).
An understanding of IVD medical device development and applicable Global Regulations related to use of companion diagnostics and assay development in precision medicine (including EU IVDR, FDA CDx Final Rule).
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 with compliance to GxP requirements including the oversight of third-party vendors, suppliers, and partners.
Ability to incorporate business and team member 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 hard-working team
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 well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. 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 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
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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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.