Quality Risk Specialist IV (Hybrid)

Job description

Location: Lynnwood,Washington,United States POSITION SUMMARY: The Quality Risk & Compliance function establishes and maintains best practices for Quality Risk Management, Data Integrity, and Audit Readiness to support patient safety, product quality, and cGMP compliance at PTx. The Quality Risk & Compliance Specialist is responsible for identifying, assessing, documenting, and monitoring quality risks associated with cGMP manufacturing, testing, and supporting GxP operations. PRIMARY RESPONSIBILITIES: - Serves as a subject matter expert (SME) for Quality Risk Management and Data Integrity programs, providing guidance to cross-functional teams and site stakeholders. - Facilitates cross-functional teams in the application of Quality Risk Management and Data Integrity principles across GxP manufacturing, testing, and support operations. Supports GxP change controls by: - Participating in pre-change planning meetings - Representing Quality Risk at Change Review Board meetings - Assessing the impact of proposed changes on existing risk assessments and the living risk library - Determining when a change requires a formal risk assessment - Ensuring applicable risk assessments are updated,...