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Senior Manager, In-Vitro Diagnostics/ Companion Diagnostics/ Precision Medicine Quality

Employer
Amgen
Location
Washington D.C., District of Columbia
Start date
Jan 11, 2025
View more categoriesView less categories
Discipline
Quality, Quality Control
Required Education
High School or equivalent
Position Type
Full time
Hotbed
Best Places to Work

Job Details

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 award-winning 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.

Senior Manager, In-Vitro Diagnostics/ Companion Diagnostics/ Precision Medicine Quality

What you will do

Lets do this! Lets 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 Amgens 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 Amgens 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 Amgens 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 Amgens 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

  • Masters degree and 4 years of quality, regulatory, or Companion Diagnostic experience OR

  • Bachelors degree and 6 years of quality, regulatory, or Companion Diagnostic experience OR

  • Associates 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, 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 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.

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Company info
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States

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