Synthetics Principal Product Quality Leader

Provide technical leadership to Amgen’s Product Quality organization for synthetic programs. Lead cross-functional efforts to develop and implement strategies for quality across late-phase and commercial synthetic programs, including ownership and review of GMP and regulatory documents, change control and regulatory submissions, product data management, comparability assessments, annual product reviews, and product quality risk management. Drive risk-based evaluation of complex process and product quality data, develop patient-oriented strategies, and communicate complex information effectively to senior Quality leadership and regulatory agencies. Collaborate with Product Quality Leaders, International Quality, Quality Control, Regulatory, Process Development, QA, and other departments to ensure product health from research to manufacturing. Prefer on-site support at Amgen locations with remote option considered where applicable. Key responsibilities include site and method transfers, NC impact statements, regulatory filing sections, RTQs, and cross-functional support for late-phase programs. Qualifications include advanced degrees with substantial experience in regulated environments, strong knowledge of cGMP and international regulatory expectations, and excellent written and verbal communication. The role offers competitive benefits, potential flexible work models, and a framework for career development within Amgen.”,