Global Product Quality Strategy Leader

Amgen SA; Thousand Oaks (CA); Hybride; USD 180 000 - 240 000; Plein temps

Résumé du poste

Amgen seeks a Principal Product Quality Leader to provide technical leadership within the Product Quality Team. The role focuses on ownership of GMP and regulatory documents, comparability, stability, and product data management to support late-stage and commercial biologics.

You will interact with Regulatory, QA, and Manufacturing groups to drive program improvements, investigations, and submissions, ensuring product quality and compliance across functions.

Qualifications

• Doctorate or higher with 2+ years in Quality, Operations, Scientific or Manufacturing roles.
• Master’s with 4+ years in Quality, Operations, Scientific or Manufacturing roles; Bachelor’s 6+ years; Associate’s 10+ years; HS diploma 12+ years.

Responsabilités

• Provide cross-functional quality leadership for late-phase and commercial programs, including annual product reviews and regulatory filings.
• Evaluate complex process and product quality data to develop patient-focused strategies and solutions.
• Own, author, and review GMP/regulatory documents; support product quality risk assessments and regulatory submissions.

Connaissances

Cross-functional leadership

Oral and written communication

Regulatory knowledge (cGMP)

Data management

Problem solving

Team collaboration

Formation

Doctorate degree

Master’s degree

Bachelor’s degree

Associate's degree

High School Diploma

Description du poste

Amgen seeks a Principal Product Quality Leader to provide technical leadership within the Product Quality Team. The role focuses on ownership of GMP and regulatory documents, comparability, stability, and product data management to support late-stage and commercial biologics.

You will interact with Regulatory, QA, and Manufacturing groups to drive program improvements, investigations, and submissions, ensuring product quality and compliance across functions.