Associate Director, Quality Assurance

Department:107100 QualityLocation:San Diego, USA- RemoteBe 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 Associate Director, Quality Assurance is responsible for providing GxP quality/compliance support and/or oversight of the quality system at Travere Therapeutics and those of contract manufacturing, storage and distribution organizations.

Responsibilities:Lead, manage and perform critical Quality Assurance GMP tasks relating to Small and/or Large Molecule Drug Substance and Drug Product activities/projectsServes as a QA point of contact on manufacturing, areas include:

Support the oversight of manufacturing, issue resolution, problem solving and Quality System related activities (e.g. document control, SOP management, operation of QMS)Liaise with Project Teams working closely with project stakeholders and managementManage internal/external day-to-day Quality issues as they ariseAid in the development, update, implementation, and management of supplier Quality AgreementsManage and provide support of the Quality System activities including product/process deviations, validation, and Batch Record ReviewProactively identify and mitigate key cross-functional and vendor issues independently with limited need to escalateServe as the Person-In-Plant activities for assigned initiatives/projects Suppliers, as necessarySupport vendor management oversight while effectively resolving issues escalated from the project teamsProactively and effectively communicate within Quality Assurance and other appropriate functions regarding the development, progress, activities, and results for assigned responsibilities

Support Regulatory Authority InspectionsParticipate in Quality Management Review, Annual Product Review, Material Review Board, Quality Compliance Operational Committee and Recall Committee activities, as neededAid in the Validation efforts, projects, and action items including validations of: Process; Facilities, Utilities, Equipment (FUE), Shipping and CleaningEnsure compliance with applicable laws, regulations and guidelines for Travere Therapeutics' contract manufacturing organizationsDraft and revise QA controlled documentsReview and approve GxP related documents, as requestedTrack deliverable progress versus timelines and goalsEnsure appropriate record-keepingProvide, facilitate retrieval of, and review relevant regulatory submissions, as requestedEducation / Experience Requirements:Bachelor's degree in related Life Sciences discipline such as Chemistry, Biology, or Chemical Engineering. Master's degree preferred. Equivalent combination of education and applicable job experience may be consideredMinimum 8 years of experience in Biotech or Pharmaceutical industry working in an FDA regulated industry in QA or a related fieldMinimum of 5 years of Quality Assurance auditing experience preferredAdditional Skills / Experience:The ideal candidate will embody Travere's core values: Patient-Inspired, Courageous, Promote Community, and Stronger TogetherIn-depth knowledge of and ability to interpret and apply GxP, FDA and ICH regulations and guidelinesProven ability in driving GxP process improvement initiativesExperience with Microsoft based applications and ability to learn internal electronic applications/systems. Experience with eQMS systems (e.g., VEEVA) is a plusStrong professional experience in a similar role within the pharmaceutical industry, both small and large molecule pharmaceuticalsWell organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environmentExcellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexityStrong interpersonal and organizational skills and excellent verbal and written communication skills are requiredAbility to travel 20-30% domestic and internationally

#J-18808-Ljbffr