Senior Product Quality Leader – Biologics

Amgen; United States; Remote; USD 139,000 - 188,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Medical/Dental/Vision Insurance

Stock-based incentives

Flexible work models

Job summary

Amgen is seeking a Principal Product Quality Leader to guide cross-functional teams across late-stage and commercial biologics programs. You will own GMP documentation, lead regulatory filings, and drive product quality assurance activities with global partners.

This role requires strong leadership, deep cGMP knowledge, and the ability to translate complex data into action across Regulatory, QA, and Manufacturing.

Qualifications

• PhD or equivalent with relevant quality/Manufacturing experience.
• Master’s/BS with 4–6 years of quality/scientific or manufacturing experience.
• Proven knowledge of cGMP and regulatory expectations.
• Strong data management and analytical skills.
• Experience in regulatory submissions or inspections is preferred.

Responsibilities

• Provide cross-functional quality leadership for late-phase and commercial programs, including reviews and regulatory filings.
• Lead risk-based evaluation of complex process and product data to drive patient-focused strategies.
• Coordinate interface between research, development and manufacturing to ensure product health.

Skills

Oral and written comms

GMP knowledge

Data management

Regulatory awareness

Cross-functional collaboration

Analytical thinking

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High School Diploma/GED

Job description

Amgen is seeking a Principal Product Quality Leader to guide cross-functional teams across late-stage and commercial biologics programs. You will own GMP documentation, lead regulatory filings, and drive product quality assurance activities with global partners.

This role requires strong leadership, deep cGMP knowledge, and the ability to translate complex data into action across Regulatory, QA, and Manufacturing.