Product Quality Specialist

Role: Product Quality Specialist focused on stability management for innovative medicines, overseeing product quality from late-stage development through full commercial lifecycle. Responsibilities include managing stability protocols and reports, supporting regulatory filings, and acting as a SME in stability, with accountability for complex or high-value product families. Collaborates across PQI/PQO/PQL and supports continuous improvement within the Stability Center of Excellence. Requirements: 6-8 years of industry experience, Bachelor's Degree, strong understanding of stability regulations, proficiency with SOPs, and ability to work independently. Preferred skills include quality management systems, regulatory environment knowledge, and problem-solving capabilities. High-Value: Stability management, late-stage development, regulatory support, complex biologics or innovative medicines, GxP compliance. Work setup: Based in Raritan or Titusville, NJ, with no explicit travel requirements stated.