GCP Auditor - Global R&D Audit

Amgen; United States; Remote; USD 105,000 - 142,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental, vision coverage

Disability insurance

Flexible spending accounts

Discretionary annual bonus

Stock-based incentives

Award-winning time-off plans

Flexible work models

Job summary

Amgen is seeking a GCP Auditor for the Global R&D Audit team. You will plan, conduct and report audits across a global remit, lead complex GCP audits and support regulatory inspections as needed. This role requires staying ahead of compliance risks and contributing to quality process improvements.

You may travel up to 40% internationally and will engage with cross-functional teams to ensure rigorous clinical trial governance throughout development and post-marketing activities.

Qualifications

• Doctorate degree or Master’s with 2 years of scientific discipline, medical sciences or pharmacy experience or Bachelor’s with 4 years, or Associate’s with 8 years, or high school diploma with 10 years of scientific discipline, medical sciences or pharmacy experience.

Responsibilities

• 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 development of R&D Quality cross functional controlled documents.

Skills

Excellent written and verbal comms

Education

Doctorate degree

Master’s degree + 2 years experience

Bachelor’s degree + 4 years experience

Associate’s degree + 8 years experience

High school diploma / GED + 10 years experience

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-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.

GCP Auditor - Global R&D Audit

What you will 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.

Basic Qualifications

• Doctorate degree OR Master’s degree and 2 years of scientific discipline, medical sciences or pharmacy experience OR Bachelor’s degree and 4 years of scientific discipline, medical sciences or pharmacy experience OR Associate’s 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

• 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.

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.

Equal Opportunity employer

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. .

Salary Range

104,725.10USD -141,686.90 USD

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