Product Quality Associate Director

Role: Product Quality Associate Director, leading technical quality oversight for late-stage or commercial biologics at Amgen. Objectives: ensure product quality strategies align with regulatory standards and support manufacturing and development programs. Responsibilities: provide leadership within Product Quality teams, coordinate with cross-functional departments (Regulatory, QC, Process Development, QA), and oversee activities like product filings, change controls, stability, and comparability assessments. Serve as the Product Quality representative in delivery teams, influence quality strategies, and author/review regulatory documents. Qualifications: Doctorate with 3+ years or Master's with 5+ years in Quality, Operations, or related fields; experience with biologics and regulated environments; prior regulatory documentation experience preferred. Skills: strong scientific data management, cGMP knowledge, effective communication, and problem-solving abilities; proficient in global regulatory expectations. High-Value: biologic products, late-stage or commercial development, regulatory filings, GMP compliance, cross-functional collaboration. WorkSetup: not specified, but likely hybrid or onsite.