Senior Manager, In-Vitro Diagnostics/Precision Medicine Quality

Amgen; United States; Remote; USD 132,000 - 179,000; Full time

Job summary

Amgen seeks a Senior Manager in-Vitro Diagnostics/Companion Diagnostics/Precision Medicine Quality to lead quality oversight of IVDs in global clinical trials. The role reports to the Director of Precision Medicine and Diagnostics Quality within R&D Quality and supports testing laboratories and diagnostic partners.

The position emphasizes proactive, risk-based Quality strategies for IVD devices, collaboration with partners, and ensuring compliance with EU IVDR and FDA CDx requirements across

Qualifications

• Doctorate with 2 years of quality, regulatory or Companion Diagnostic experience OR
• Master’s with 4 years of quality, regulatory or Companion Diagnostic experience OR
• Bachelor’s with 6 years of quality, regulatory or Companion Diagnostic experience OR
• Associate’s with 10 years of quality, regulatory or Companion Diagnostic experience OR
• High school diploma / GED with 12 years of quality, regulatory or Companion Diagnostic experience

Responsibilities

• Provide quality oversight of IVD medical devices in precision medicine trials.
• Offer SME guidance on regulatory/quality oversight of IVDs incl. CDx, LDTs, assays.
• Support inspections and ensure inspection readiness.
• Collaborate with partners to ensure compliant IVDs/assays in trials.
• Advance quality management strategies for EU/US regulatory landscapes.
• Support quality agreements, protocol reviews, and ICF reviews.

Skills

Quality management

Regulatory knowledge

CDx/IVD expertise

Clinical trial quality

Quality systems

Education

Doctorate degree

Master's degree

Bachelor's degree

Associate's degree

High school diploma / GED

Tools

Veeva

TrackWise

Job description

Career Category

Quality

Job Description

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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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 Quality 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 and 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.
• Support clinical trial inspections from health authorities (including inspection readiness and managing findings). This includes drug and device inspections.
• Collaborate with Amgen’s IVD and diagnostic partners to ensure quality oversight of IVDs/ assays used within Amgen drug clinical trials to ensure industry best practices and all regulations are complied with.
• 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 at EU clinical trial sites, either as a site monitor or study management.
• 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).
• Working knowledge of IVD medical device development (i.e. design controls) 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.
• Understanding of EU IVD performance studies under EU IVD Regulation.
• 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.

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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

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.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of 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. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

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Salary Range

132,037.30USD -178,638.70USD