GCP Auditor - Global R&D Audit

BioSpace; Washington (District of Columbia); Sur place; USD 130 000 - 180 000; Plein temps

Avantages offerts par ce poste

Health and welfare plans

Retirement and Savings Plan

Stock-based incentives

Flexible work models

Résumé du poste

Amgen seeks a GCP Auditor to join its Global R&D Audit team, conducting routine and lead audits across an international remit. The role supports R&D Quality and interfaces with regulatory inspections to ensure GCP compliance during development and post-marketing phases.

The candidate will drive risk identification, process improvements, and cross-functional documentation development, with up to 40% travel internationally.

Qualifications

• GCP auditing experience or regulatory inspections experience.
• Strong ability to communicate risks to management.
• Experience conducting audits across global settings.

Responsabilités

• 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 participate in regulatory authority inspections.
• Contribute to or lead R&D Quality process improvement initiatives.
• Author and contribute to R&D Quality controlled documents.

Connaissances

GCP auditing

Regulatory inspections

Cross-functional collaboration

Formation

Doctorate degree

Masters degree in science

Bachelors degree in science

High school diploma / GED

Description du poste

GCP Auditor - Global R&D Audit

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.

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

• 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
• 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.

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.

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.

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.

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.