Principal Product Quality Leader, Synthetics

Amgen Inc.; Thousand Oaks (CA); On-site; USD 139,000 - 188,000; Full time

Benefits offered by this job

Retirement plan

Medical/Dental/Vision insurance

Life and disability insurance

Flexible spending accounts

Bonus program

Stock-based long-term incentives

Paid time off

Job summary

Amgen in Thousand Oaks, CA is seeking a Principal Product Quality Leader (Synthetics) to provide technical expertise and product leadership within the Product Quality organization. You will work with Product Quality Leaders, International Quality, and Regulatory to manage projects, investigations, and regulatory submissions for synthetic programs.

The role requires strong knowledge of cGMP, quality systems, and cross-functional leadership across QA, Manufacturing, and Process Development.

Qualifications

• Basic Qualifications include doctorate/masters/bachelor/associate/high school with years of experience in Quality, Operations, Scientific or Manufacturing.
• Preference for candidates with degree in chemistry, biochemistry, biology or related pharma sciences and relevant GMP/regulatory exposure.
• Experience in leading cross-functional teams, writing or reviewing regulatory filings and handling non-conformance investigations.

Responsibilities

• Provide effective, cross-functional quality leadership and PDT deliverables for late phase and commercial synthetic programs.
• Support evaluation of complex process and product quality data and develop patient-oriented strategies.
• Demonstrate proficiency in oral and written communication to Product Quality leadership and regulatory agencies.
• Demonstrate knowledge of cGMP and international regulatory expectations.

Skills

Quality leadership

GMP knowledge

Regulatory knowledge

Cross-functional team

Project management

cGMP understanding

Communication skills

Education

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

Job description

Amgen in Thousand Oaks, CA is seeking a Principal Product Quality Leader (Synthetics) to provide technical expertise and product leadership within the Product Quality organization. You will work with Product Quality Leaders, International Quality, and Regulatory to manage projects, investigations, and regulatory submissions for synthetic programs.

The role requires strong knowledge of cGMP, quality systems, and cross-functional leadership across QA, Manufacturing, and Process Development.