Senior Associate Quality Compliance

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.