GCP Auditor - Global R&D Audit

BioSpace; Washington (District of Columbia); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Competitive benefits

Travel opportunities

Job summary

Amgen seeks a GCP Auditor to join the Global R&D Audit team within the R&D Quality organization. You will plan, conduct, and report GCP audits across international sites and support regulatory inspections.

The role requires leading complex audits, identifying risks, and driving process improvements while traveling up to 40% internationally.

Qualifications

• Doctorate degree OR
• Masters degree with 2+ years in scientific discipline, medical sciences or pharmacy
• Bachelors degree with 4+ years in scientific discipline, medical sciences or pharmacy
• Associates degree with 8+ years in scientific discipline, medical sciences or pharmacy
• HS diploma / GED with 10+ years in scientific discipline, medical sciences or pharmacy

Responsibilities

• Plan, conduct and report routine and direct GCP audits internationally.
• Serve as a lead auditor for complex GCP audits.
• Identify and communicate compliance risks to R&D Quality management.
• Host and/or contribute to regulatory authority inspections.
• Contribute to or lead R&D Quality process improvement initiatives.
• Author and contribute to R&D Quality cross functional controlled documents.

Skills

GCP auditing

Regulatory inspections

Global audits

Data mining / analytics

Excellent communication

Education

Doctorate degree or equivalent

Masters degree + 2 years experience

Bachelors + 4 years experience

HS diploma + 10 years experience

Tools

Regulatory tools

Job description

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. 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, 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.

GCP Auditor - Global R&D Audit

What You Will Do

Lets do this. Lets change the world. You would be joining Amgens R&D Quality Audit Team of expert, professional and widely experienced individuals working with a global remit across Amgens portfolio in all stages of development and post marketing. The R&D Quality audit team is part of Amgen's R&D Quality Group.

Responsibilities

In this vital role within R&D Quality you will be planning and participating in global audits of Amgens 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

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:

Basic Qualifications

• Doctorate degree OR
• Masters degree and 2 years of scientific discipline, medical sciences or pharmacy experience OR
• Bachelors degree and 4 years of scientific discipline, medical sciences or pharmacy experience OR
• Associates degree and 8 years of scientific discipline, medical sciences or pharmacy experience OR
• High school diploma / GED and 10 years of scientific discipline, medical sciences or pharmacy experience

Preferred Qualifications

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

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.

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.