Remote-Eligible Principal Synthetic Quality Leader

Amgen; Thousand Oaks (CA); Hybrid; USD 139,000 - 188,000; Full time

Benefits offered by this job

Retirement plan

Stock-based incentives

Flexible work arrangements

Job summary

Amgen Inc. (IR) seeks a Principal Product Quality Leader (Synthetics) to lead cross-functional quality efforts for late-stage and commercial synthetic programs in a global manufacturing context.

You will own product quality tasks, author and review GMP/regulatory documents, and collaborate across Regulatory, Process Development, and Manufacturing teams. The role emphasizes hands-on quality leadership, risk assessment, and interactions with regulators.

Qualifications

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

Responsibilities

• Provide cross-functional quality leadership to support late phase and commercial synthetic programs.
• Evaluate complex process and product quality data to develop patient-oriented strategies.
• Communicate complex information to Product Quality leadership and regulatory bodies.
• Ensure knowledge of cGMP and international regulatory expectations.

Skills

Quality leadership

Cross-functional collaboration

Regulatory knowledge

Oral and written communication

cGMP knowledge

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High School Diploma

Job description

Amgen Inc. (IR) seeks a Principal Product Quality Leader (Synthetics) to lead cross-functional quality efforts for late-stage and commercial synthetic programs in a global manufacturing context.

You will own product quality tasks, author and review GMP/regulatory documents, and collaborate across Regulatory, Process Development, and Manufacturing teams. The role emphasizes hands-on quality leadership, risk assessment, and interactions with regulators.