Senior Quality Assurance Associate - GMP/GDP Auditing

Department: 107100 Quality Location: San Diego, USA- Remote Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease. At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients.Our work is rewarding - both professionally and personally - because we are making a difference. We are passionate about what we do. We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission - to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community. At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients*.* Position Summary: The Senior Quality Assurance Associate - GMP/GDP Auditing is responsible for executing GMP and GDP audits, supporting supplier qualification, compliance oversight, and inspection readiness activities across Travere's external partner network. This role serves as a Quality Assurance subject matter expert for supplier audits, risk assessments, and external quality management, ensuring compliance with applicable regulatory requirements and company standards. The position partners closely with Technical Operations, Supply Chain, Regulatory Affairs, Clinical Operations, Pharmacovigilance, and other cross-functional teams to support a robust supplier qualification and audit program. Responsibilities: GMP/GDP Auditing - Conduct risk-based GMP and GDP audits of contract manufacturers, testing laboratories, distribution providers, logistics partners, and/or medical device manufacturers. - Plan, execute, and document on-site, remote, and hybrid interna/external audits. - Assess compliance with applicable FDA, EU, ICH, ISO, and other regulatory requirements. - Prepare audit reports, observations, and risk assessments. - Review supplier responses and evaluate corrective and preventive action (CAPA) plans. - Track audit findings and quality actions through closure. - Support audit schedule preparation, audit metrics, trending, and management reporting. - Communicate significant audit findings and compliance risks to Quality leadership and relevant cross-functional stakeholders. Supplier Qualification & Oversight - Perform supplier qualification, requalification assessments and risk-based recommendations. - Review supplier documentation, inspection histories, quality metrics, and compliance records. - Maintain supplier qualification records, risk assessments, and Approved Supplier Lists (ASLs). - Monitor supplier performance, quality events, change notifications and assess their potential impact on product quality, patient safety, and regulatory compliance. - Escalate significant quality or compliance risks as appropriate. Quality Systems & Compliance - Support GxP inspection readiness activities. - Utilize electronic Quality Management Systems (e.g., Veeva Vault Quality Suite) to manage quality events and actions. - Support the development, revision, and maintenance of quality procedures, work instructions, and related documentation. - Participate in regulatory inspections, partner audits, and due diligence activities.