New · posted Oct 28
Amgen · Biotechnology
Quality Assurance Senior Manager
- Remote, US
- Remote
- Full-time
- Manager
The role
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.
What you need
5 ways to qualify
PhD
+ 2 years of experience
Doctorate degree and 2 years of Quality experience OR
- or
Master’s
+ 4 years of experience
Master’s degree and 4 years of Quality experience OR
- or
Bachelor’s
+ 6 years of experience
Bachelor’s degree and 6 years of Quality experience OR
- or
Associate
+ 10 years of experience
Associate’s degree and 10 years of Quality experience OR
- or
High school
+ 12 years of experience
High school diploma / GED and 12 years of Quality experience
Basic Qualifications
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.
Preferred Qualificationsnice to have
- 10+ years biotech or pharmaceutical industry experience
- 5+ years of experience overseeing quality of suppliers
- Experience with leading audits
- Technical knowledge related to primary components
- Experience with Quality Processes and systems such as Trackwise and Veeva
- Experience with quality oversight of primary components
- History of presenting during inspections and audits
- Able to facilitate and influence senior stakeholders and partners
- Able to successfully prioritize workload and meet timelines
- Ability to negotiate a strategic position after receiving feedback from multiple sources
- Strong project management, problem-solving, and analytical skills
- Demonstrated ability to lead cross-functional teams, consistently deliver timely, and high-quality results
- Collaborates and communicates well with others, able to balance divergent inputs from various partners and drive issue resolution
- Ability to operate in a matrixed or team environment with site, functional, and executive leadership
- Experience with relationship management with external parties
- Savvy with data and Artificial Intelligence tools
What you'll do
Let’s do this. Let’s change the world. This QA Sr. Manager role will be responsible for the quality oversight of primary component suppliers. This person is an integral member of the Amgen cross-functional supplier team(s) that includes, but is not limited to, business operations, process development, supply chain and combination product quality.
- Act as the quality lead for supplier relationships, from onboarding through disengagement, ensuring performance through robust proactive monitoring, technical site visits, and continuous improvement.
- Perform proactive quality management of suppliers, ensuring compliance with global regulatory standards, including but not limited to GDP, GMP, ISO, etc and Amgen’s industry leading expectations.
- Negotiator and owner of quality agreements
- Prepare external sites for inspections including development of inspection playbooks.
- Represent Amgen at external supplier site during product-specific Regulatory Inspections and/or during notified body audits of supplier, as applicable or required
- Present on topics during inspections demonstrating appropriate behaviors and knowledge of the subject areas
- Review/Approve supplier investigations, events and change notifications
- Quality approver of deviations, change controls, CAPA, CAPA EVs
- Identify and mitigate risk at the supplier and/or escalate to management
- Perform Person in Plant activities, as deemed appropriate
- Drive audit commitments to completion
- Lead supplier audit preparation and identify areas of focus
- Continuously assess supplier status through periodic monitoring reporting
- Partner with Operations site lead on issues, improvements, site performance and overall relationship management
- Understand and implement GMP requirements internally and externally
The follow applies:
- Up to 20% of domestic and international travel required
- This role may work on-site at one of the following locations: Thousand Oaks, CA, Cambridge, MA, Greenwich, RI, Tampa, FL, or Puerto Rico.
- Open to remote associates in any US location
Pay and benefits
$132,000 – $179,000 a year
Employer provided132,037.30USD -178,638.70 USD
What you can expect of us
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.
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:
Apply now and make a lasting impact with the Amgen team.
Working conditions
Career Category
Quality
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.
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.
Equal opportunity, accessibility and legal noticesAmgen's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 28, 2026
Salary intelligence
How the pay compares
This role's midpoint is 3% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Manager roles in the US121 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $132,000 | — | $179,000 |
| All US (middle half) | $131,500 | $150,500 | $167,500 |
This role: Amgen's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 28, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 961 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Amgen's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 46 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk10
- Collaboration and leadership10
- GMP and compliance9
- Investigations and CAPA2
- Lab testing and methods1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Amgen on Regulatory Jobs
- 34
- Open roles
- 31
- Distinct roles
- 6
- Locations
By discipline
- Quality25 74%
- Regulatory7 21%
- Compliance & Safety2 6%
By level
- Manager14 41%
- Senior & Principal11 32%
- Associate & Specialist6 18%
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Quality Assurance Senior Manager at Amgen
Open until filled. $132K–$179K a year, employer provided.