Senior Associate Quality Compliance

Amgen Inc. (IR); Chicago (IL); Hybrid; USD 89,000 - 121,000; Full time

Benefits offered by this job

Total rewards plan

Stock-based incentives

Retirement plan

Flexible work models

Job summary

Amgen Inc. (IR) is seeking a Senior Associate Quality Compliance to strengthen the RDQ Quality Management System and provide quality support for clinical development programs. The role involves handling audits, deviations, CAPAs, and regulatory communications with a focus on process automation.

You will collaborate with RDQ Compliance Managers and Clinical Study Teams, preparing metrics and ensuring timely documentation. Strong knowledge of GCP, ICH E6R3, and regulatory procedures is essential.

Qualifications

• Master’s degree or Bachelor’s degree with healthcare experience.
• Clinical R&D knowledge and GCP compliance required.
• Knowledge of ICH E6R3 and 21 CFR is preferred.

Responsibilities

• Strengthen and advance Amgen’s RDQ Quality Management System (QMS).
• Provide quality support for programs across clinical development stages.
• Input audit responses into QMS and site inspection data into the IMS.
• Develop and close CAPAs with timely objective evidence.
• Prepare weekly metrics for the General Medicine team and manage logbooks.

Skills

Clinical R&D knowledge

GCP Quality Compliance

ICH E6R3 knowledge

Regulatory submissions

Microsoft Office

Strong communication

Interpersonal skills

Pressure resilience

Education

Master’s degree

Bachelor’s degree + 2 years healthcare

Associate’s degree + 6 years healthcare

High school diploma + 8 years healthcare

Job description

Career Category Project Management 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.

Senior Associate Quality Compliance

What you will do

Let’s do this! Let’s change the world! In this vital role you will Strengthen and advance Amgen’s R&D Quality Management System (QMS). Provide quality support for Amgen programs for all stages of products in clinical development.

Supports the R&D Quality (RDQ) Compliance Managers in the following areas:

• Input of audit responses into QMS
• Input of site inspection data into the Inspection Management System
• Working with deviation owners to ensure the timely development and closure of CAPAs.
• Ensuring deviation owners are submitting objective evidence within agreed timelines, where applicable
• Ensuring the timely preparation and submission of documentation to the Potentially Reportable Serious Breach committee
• Collaboration with the Clinical Study Team, as directed by the RDQ Compliance Manager, to facilitate communication
• Prepare weekly metric reports for the General Medicine team, including, but not limited to, open deviations, CAPAs, serious breaches, audit and inspection findings.
• Highlighting overdue items and supporting the RDQ compliance managers to ensure timely closure.
• Working with the RDQ Compliance Manager and data quality analytics team to assess the effectiveness of metric reports and optimize as required
• Facilitate Rare Disease team meetings, including agenda and presentation preparation.
• Maintain a Decision & Action log, follow up with action owners until resolution.
• Management of a Q&A log.
• Support inspection readiness activities under the supervision of the RDQ Compliance Manager
• Quality oversight of small clinical programs under the guidance of the RDQ Compliance Manager
• Demonstrated ability to leverage artificial intelligence (AI) tools and technologies to streamline workflows, drive process automation, and support data-driven decision-making.
• Must be adept at identifying opportunities to apply AI for operational efficiency and continuous improvement initiatives.
• Support the RDQ Compliance Manager to develop lessons learned and best practices documentation
• Collaborate with other Amgen R&D Quality functions as required
• Maintenance of Rare Disease SharePoint site and Teams channels

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:

Basic Qualifications

Master’s degree OR Bachelor’s degree and 2 years of scientific or healthcare related experience OR Associate’s degree and 6 years of scientific or healthcare related experience OR High school diploma / GED and 8 years of scientific or healthcare related experience

Preferred Qualifications

• Understanding of Clinical R&D activities and Global Regulations
• Experience working within GCP Quality Compliance preferred
• Knowledge and application of international requirements of Good Clinical Practice (GCP)(required) or Good Pharmacovigilance Practice (GPV) and/or Good Laboratory Practice (GLP)
• Knowledge of R&D processes and operations
• Knowledge of the Regulatory Submission and Inspection Management procedures
• Ability to work under pressure and maintain flexibility
• Attention to detail
• Knowledge of ICH E6R3 as well as 21 CFR 11, SO, 54, 56, 58, 312, and 812
• Proficiency in Microsoft Office Professional, proactive demeanor
• Strong interpersonal skills
• Excellent written and verbal communication skills

What you can expect of us

From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

Salary and Benefits

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted.

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.

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 Statement

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.

Salary Range 89,168.40USD -120,639.60 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