Senior Product Quality Leader (Biologics)

Regulatory Jobs; United States; Hybrid; USD 139,000 - 188,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Medical, dental, and vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus

Job summary

Amgen is seeking a Principal Product Quality Leader to oversee quality leadership across late-stage and commercial biologics programs, including product reviews, comparability, stability, and regulatory filings. You will coordinate with Regulatory, Quality Assurance, and Manufacturing to drive product quality and process improvements.

Responsibilities include data-driven evaluation, risk assessment, and development of patient-centered quality strategies, ensuring compliance with cGMP and

Qualifications

• Doctorate degree & 2 years of Quality, Operations, Scientific, or Manufacturing experience OR
• Master’s degree & 4 years of Quality, Operations, Scientific, or Manufacturing experience OR
• Bachelor’s degree & 6 years of Quality, Operations, Scientific or Manufacturing experience OR
• Associate's degree and 10 years of Quality, Operations, Scientific or Manufacturing experience OR
• High School Diploma/GED and 12 years of Quality, Operations, Scientific or Manufacturing experience

Responsibilities

• Provide effective, cross-functional quality leadership for late phase and commercial programs, incl. annual product reviews, specifications, comparability, stability, site transfers and regulatory filing sections.
• Support risk-based evaluation of complex process and product quality data and develop patient-oriented strategies.
• Interface between research, global development and manufacturing to ensure molecules become medicines.

Skills

Oral and written communication

cGMP knowledge

Data management and organization

Education

Doctorate

Master's

Bachelor's

Associate

High School Diploma

Job description

Amgen is seeking a Principal Product Quality Leader to oversee quality leadership across late-stage and commercial biologics programs, including product reviews, comparability, stability, and regulatory filings. You will coordinate with Regulatory, Quality Assurance, and Manufacturing to drive product quality and process improvements.

Responsibilities include data-driven evaluation, risk assessment, and development of patient-centered quality strategies, ensuring compliance with cGMP and