Senior Associate, R&D 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

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.