Senior Quality Specialist, Technical

Role: Senior Specialist in Quality Assurance Technical supporting validation and qualification activities for solid oral dose and biologic products at Travere Therapeutics. Primary objectives include ensuring product quality and compliance with regulatory standards through document review, validation support, data verification, and investigation oversight. Responsibilities encompass managing validation protocols and reports, change controls, investigations, and ensuring alignment with GMP and international guidelines. Requires a Bachelor’s in life sciences (Chemistry, Biology, Chemical Engineering or related), with 5+ years of quality experience in biotech or pharma, specifically in GMP QA, validation, or related systems. Knowledge of electronic QMS (preferably Veeva), cGMPs (CFR/ICH), and validation processes is essential. Preferred skills include strong technical writing, organizational, and interpersonal abilities, with excellent communication and problem-solving skills. Ability to travel 10%, with on-site work at San Diego and remote flexibility. The role demands a driven, patient-focused professional embodying core values of courage, community, and teamwork, supporting ongoing clinical and commercial manufacturing activities for rare disease therapies.