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Manager, In-Vitro Diagnostics/Companion Diagnostics/Precision Medicine Quality
3 months ago
HOW MIGHT YOU DEFY IMAGINATION?
Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
MANAGER, IN-VITRO DIAGNOSTICS/COMPANION DIAGNOSTICS/PRECISION MEDICINE QUALITYLive
What you will do
Lets do this Lets change the world In this remote role you will report to the Senior Manager, of Precision Medicine and In-Vitro Diagnostics (IVD) 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 In-Vitro Diagnostics/ 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 In-Vitro Diagnostic (IVD) medical devices used within Amgens precision medicine clinical trials.
Provide subject matter expertise on the development and operation of IVDs, including Companion Diagnostics (CDx), Laboratory Developed Test (LDTs), assays, within the area of precision 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.Win
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.Basic Qualifications:
Doctorate degree OR
Masters degree and 3 years of quality, regulatory, or Companion Diagnostic experience OR
Bachelors degree and 5 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
In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
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 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 high performing team
Thrive
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.
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.
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 possibleApply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.careers.amgen.com
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.
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.
