Senior Associate Quality Compliance

Regulatory Jobs; United States; Hybrid; USD 89,000 - 121,000; Full time

Benefits offered by this job

Retirement plan

Bonus program

Stock-based incentives

Time-off plans

Flexible work models

Job summary

Amgen is seeking a Senior Associate Quality Compliance to strengthen the R&D Quality Management System and provide quality support across clinical development programs. You will collaborate with RDQ Compliance Managers and help ensure readiness for inspections and audits.

Responsibilities include inputting audit responses, managing CAPA timelines, and producing weekly metrics for the General Medicine team. Proficiency in GCP and regulatory knowledge is required.

Qualifications

• Advanced degree in a scientific or healthcare field or equivalent experience.
• Experience in clinical R&D quality compliance and GCP.
• Knowledge of regulatory submission and inspection procedures.

Responsibilities

• Strengthen and advance Amgen's R&D QMS across clinical development.
• Input audit responses into QMS and site inspection data into IMS.
• Work with deviation owners to develop and close CAPAs on time.

Skills

GCP Quality Compliance

Regulatory Submissions

ICH E6(R3) familiarity

Data analytics

Communication skills

Education

Master's degree

Bachelor's degree with 2 years experience

Associate's degree with 6 years experience

High school diploma / GED with 8 years experience

Tools

Microsoft Office

Job description

Senior Associate Quality Compliance

Join Amgen's mission of serving patients. Since 1980, Amgen has helped pioneer biotech in the fight against the world's toughest diseases. It focuses on four therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease.

What you will do

In this role you will strengthen and advance Amgen's R&D Quality Management System (QMS) and provide quality support for Amgen programs at all stages of clinical development. You will support 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 make sure CAPAs are developed and closed on time, and that objective evidence is submitted within agreed timelines
• Preparing and submitting documentation to the Potentially Reportable Serious Breach committee on time
• Working with the Clinical Study Team to help communication
• Preparing weekly metric reports for the General Medicine team (deviations, CAPAs, serious breaches, audit and inspection findings)
• Working with the data quality analytics team to assess and improve metric reports
• Running Rare Disease team meetings and maintaining Decision & Action and Q&A logs
• Supporting inspection readiness activities
• Quality oversight of small clinical programs
• Using AI tools to streamline workflows and automate processes
• Developing lessons-learned and best-practices documentation
• Working with other Amgen R&D Quality functions
• Maintaining the Rare Disease SharePoint site and Teams channels

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
• Knowledge of GCP (required), GPV and/or GLP
• Knowledge of R&D processes and operations
• Knowledge of Regulatory Submission and Inspection Management procedures
• Knowledge of ICH E6(R3) and 21 CFR 11, 50, 54, 56, 58, 312, and 812
• Proficiency in Microsoft Office
• Attention to detail, ability to work under pressure, strong interpersonal and communication skills

What you can expect of us

• Retirement and Savings Plan with generous company contributions; medical, dental and vision coverage; life and disability insurance; flexible spending accounts
• Discretionary annual bonus program
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible

Salary Range: $89,168.40 - $120,639.60 USD

Amgen does not have an application deadline for this position. Sponsorship for this role is not guaranteed. Amgen is an Equal Opportunity employer.