QA Senior Manager

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.

Quality Assurance Senior Manager

What you will do

Lets do this! Lets change the world! In the rapidly evolving landscape of clinical trials, ensuring the quality and compliance of innovative technologies is paramount. This role reports to the Executive Director, Precision Medicine / Diagnostics and R&D Supplier Quality, and is dedicated to supporting the implementation of a comprehensive and proactive Quality Assurance (QA) strategy for diagnostic or health technology products used in Clinical Trials, including third-party collaborations and oversight. The individual in this role is crucial in managing and overseeing programs and projects related to diagnostics, imaging, digital pathology, AI models, and health tech products used for decentralized Clinical Trials and others. The responsibilities include continuous improvement, operational programs, systems, and procedures to ensure compliance with requirements, standards, and regulatory expectations while employing risk-based, scalable approaches.

The Quality strategy surrounding clinical trials technology is relevant in all aspects of research and development at Amgen, spanning from early research through the entire lifecycle of clinical development. This strategy will ensure that Amgens procedures meet internal and external quality standards, and that they are managed for optimum efficiency and effectiveness. This 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.

Key Responsibilities

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 regulated device technologies used in Amgens clinical 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 standard methodologies and all regulations.

Participate in the update, integration, and configuration of Amgen technology to ensure compliance with relevant standards and regulations

Leverage metrics (KQI, KPI leading and lagging) to drive performance and improvement

Maintain up-to-date knowledge of relevant regulations and applicable guidance and communicate impact to the business.

Perform upstream and downstream performance and compliance analysis to identify potential risks.

Represent Quality on innovative health technology or diagnostic programs as assigned

Assist other R&D Quality groups in properly channeling related items to the appropriate processes and controls

Conduct assessments, audits, and Quality investigations

Oversee department infrastructure operations, metrics, and operational excellence

Facilitate inspection readiness, conduct, and follow-through for responsibilities in scope

Willing and able to travel up to 15%

Authority

Advise program teams as Quality representative as required (fungible resource)

Review and provide input to on-topic global regulatory guidance, verification and validation documentation for HTPs or diagnostics

Conduct gap analyses and translate results into action plans

Advise / determine proper controls for in-scope technologies

Review / approve procedures and work instructions

Develop and deliver training and awareness materials for team members at all levels

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 and 2 years of Quality Management or other relevant experience OR

Masters degree and 4 years of Quality Management or other relevant experience OR

Bachelors degree and 6 years of Quality Management or other relevant experience OR

Associates degree and 10 years of Quality Management or other relevant experience OR

High school diploma / GED and 12 years of Quality Management or other relevant experience

Preferred Qualifications :

Minimum of Bachelors degree in Life sciences, Engineering, or related field.

Minimum of 7 years of professional experience Program Management, Operational Excellence, Quality, R&D, Production or a combination thereof

At least 3 years of experience in medical device industry or the pharmaceutical / biotech working within 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.)

Executive management communication experience

Ability to adapt to changing business needs

Effective and timely decision making and influencing skills

Strong project management skills / ability to lead and / or oversee numerous projects simultaneously

General knowledge of cGMP regulations, practices, and trends pertaining to Devices Quality

Demonstrated experience and results Quality oversight of innovative technologies used in a clinical trial setting

Demonstration of strong leadership, negotiation and influencing skills along with advanced communication and analytical skills

An understanding of medical device requirements and applicable Global Regulations.

An understanding of Quality Management Systems (QMS), including electronic QMS such as Veeva

Experience preferred working within research and development

Implementation of technology in a diverse R&D environment

Experience with compliance to GCP requirements including interaction with third-party vendors, suppliers, and partners

Ability to incorporate business and team member feedback into clear, efficient processes using a straightforward language and format

Innovative thinking, including the application of quality by design principles

Collaborative worker with an ability to support a high performing team

Deep experience with investigation, CAPA change management, pre- and post-mortems, and problem-solving methodologies

Willingness to learn and be persistent

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.

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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.