QA Sr Mgr

Amgen Inc. (IR); Boston (MA); Hybrid; USD 132,000 - 179,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Group medical, dental, vision

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus

Job summary

Amgen is seeking a QA Senior Manager to lead a team responsible for the quality oversight of external mechanical device suppliers. The role requires advanced degrees and extensive experience in medical devices or biotech sectors, with a focus on quality systems and regulatory alignment.

You will collaborate cross-functionally across External Supply, Process Development, and Product Quality to drive product quality and process improvements, with up to 25% travel.

Qualifications

• Degree in Biology, Engineering, Pharmaceutics, Biotechnology, or Physics.
• 10+ years in Medical Device/pharma/biotech sectors.
• Knowledge of quality systems (batch release, complaints, risk management).
• Global supplier management and device regulations.
• Strong leadership, communication, and problem-solving skills.
• Experience managing global teams, including during change.
• Travel up to 25%, domestic and international.

Responsibilities

• Supplier Oversight: Monitor quality systems and performance of external device suppliers. Define and enforce quality requirements. Manage supplier quality KPIs and risk escalations.
• Team Leadership: Manage and develop assigned team members. Collaborate with cross-functional teams across Amgen.
• Tactical Execution: Lead cross-functional initiatives and foster continuous improvement and operational excellence.

Skills

Quality systems

Global supplier management

Leadership

Communication

Regulatory knowledge

Change management

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

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. With our focus on four therapeutic areas - Oncology, Inflammation, General Medicine, and Rare Disease - we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.

QA Senior Manager

What you will do

Let's do this. Let's change the world. In this vital role you will leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses. Program manage remediation of assigned critical external mechanical device suppliers. Lead a team of quality professionals overseeing external mechanical device suppliers. Ensure compliance with scientific, regulatory, and quality standards across global operations. Collaborate cross-functionally with teams in External Supply, Process Development, and Combination Product Quality. Drive change, ensure product quality, and create a diverse and inclusive environment.

Key Responsibilities

• Supplier Oversight: Monitor quality systems and performance of external device suppliers. Define and enforce quality requirements. Manage supplier quality KPIs and risk escalations.
• Team Leadership: Manage and develop assigned team members Work collaboratively with cross functional teams across Amgen
• Tactical Execution: Lead impactful cross-functional initiatives. Foster a culture of continuous improvement and operational excellence.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The vital attribute professional we seek is a type of person with these qualifications.

Basic Qualifications

Doctorate degree and 2 years of experience OR Master’s degree and 4 years of experience OR Bachelor’s degree and 6 years of experience OR Associate’s degree and 10 years of experience OR High school diploma / GED and 12 years of experience

Preferred Qualifications

Degree in Biology, Engineering, Pharmaceutics, Biotechnology, or Physics. 10+ years in Medical Device/pharma/biotech sectors. Extensive knowledge of: Quality systems (batch release, complaints, risk management). Global supplier management and device regulations. Strong leadership, communication, and problem-solving skills. Experience managing global teams, including during change. Travel up to 25%, domestic and international.

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.

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 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.

Equal Opportunity Statement

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.

Salary Range

132,037.30USD -178,638.70 USD

Company Overview

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen