New · posted Nov 1
Amgen · Biotechnology
GCP Auditor - Global R&D Audit
- Remote, US
- Remote
- Full-time
- Senior & Principal
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. 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-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.
What you need
4 ways to qualify
Master’s
+ 2 years of experience
Master’s degree and 2 years of scientific discipline, medical sciences or pharmacy experience OR
- or
Bachelor’s
+ 4 years of experience
Bachelor’s degree and 4 years of scientific discipline, medical sciences or pharmacy experience OR
- or
Associate
+ 8 years of experience
Associate’s degree and 8 years of scientific discipline, medical sciences or pharmacy experience OR
- or
High school
+ 10 years of experience
High school diploma / GED and 10 years of scientific discipline, medical sciences or pharmacy experience
Basic Qualifications
- Doctorate degree OR
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:
Preferred Qualificationsnice to have
- Postgraduate qualification
- Participation in process improvement initiatives.
- Extensive experience conducting international auditing in GCP or as a regulatory authority inspector
- Experience of data mining, manipulation and data analytics would be advantageous
- Excellent written and verbal communication skills
What you'll do
Let’s do this. Let’s change the world. You would be joining Amgen’s R&D Quality Audit Team of expert, professional and widely experienced individuals working with a global remit across Amgen’s portfolio in all stages of development and post marketing. The R&D Quality audit team is part of Amgen's R&D Quality Group.
In this vital role within R&D Quality you will be planning and participating in global audits of Amgen’s clinical trials activities. You may also support regulatory inspections of clinical sites and Amgen facilities. The key responsibilities include:
- Plan, conduct and report routine and direct GCP compliance audits internationally.
- Serve as a lead auditor for complex GCP audits
- Identify and communicate compliance risks to R&D Quality management
- Host and/or play a role in regulatory authority inspections
- Contribute to or lead R&D Quality process improvement initiatives
- Author and contribute to the development of R&D Quality cross functional controlled documents
The role can entail up to 40% travel to international destinations
Pay and benefits
$105,000 – $142,000 a year
Employer provided104,725.10USD -141,686.90 USD
What you can expect from 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 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, accessibility and legal noticesAmgen's statements, word for word
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. 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.
Job intelligence
The context around this role
Live data · November 3, 2026
Salary intelligence
How the pay compares
This roleEmployer provided
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $105,000 | — | $142,000 |
This role: Amgen's own published range.
Career trajectory
Where this role sits in Clinical Quality Assurance
The general path across 7 open Clinical Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Amgen's own promotion track.
Career resources on Clinical Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 24 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance7
- Collaboration and leadership7
- Documentation and SOPs2
- Quality systems and risk2
- Validation and qualification1
- Clinical trial conduct1
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.
Company hiring pulse
Amgen on Regulatory Jobs
- 47
- Open roles
- 45
- Distinct roles
- 4
- Locations
By discipline
- Quality23 49%
- Regulatory12 26%
- Clinical12 26%
By level
- Manager17 36%
- Director13 28%
- Senior & Principal12 26%
More roles at Amgen
- View role
US Director of Clinical Site Monitoring and Oversight
Remote, USDirectorBiotechnology$196K–$265K
- View role
Clinical Development Medical Director, Obesity and Related Conditions
Remote, USDirectorBiotechnology$275K–$372K
- View role
Senior Director, Clinical Development Medical Director- Obesity and Related Conditions
Remote, USDirectorBiotechnology$302K–$409K
- View role
Clinical Development Medical Director, Early Development – Cardiometabolic
Remote, USDirectorBiotechnology$275K–$372K
Similar Clinical Quality Assurance roles elsewhere
- View role
Auditor - GCP
CSLKing of Prussia, PASenior & PrincipalBiotechnologySalary not listed
GCP Auditor - Global R&D Audit at Amgen
Open until filled. $105K–$142K a year, employer provided.