Kansas Action for Children, Inc
Associate Director, Quality Assurance
Kansas Action for Children, Inc, Topeka, Kansas, United States,
at Travere Therapeutics in Wichita, Kansas, United States
Job Description
Department: 107100 Quality 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 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/projects. Serve 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 management. Manage internal/external day-to-day Quality issues as they arise. Aid in the development, update, implementation, and management of supplier Quality Agreements. Manage and provide support of the Quality System activities including product/process deviations, validation, and Batch Record Review. Proactively identify and mitigate key cross-functional and vendor issues independently with limited need to escalate. Serve as the Person-In-Plant activities for assigned initiatives/projects Suppliers, as necessary. Support vendor management oversight while effectively resolving issues escalated from the project teams. Proactively and effectively communicate within Quality Assurance and other appropriate functions regarding the development, progress, activities, and results for assigned responsibilities. Support Regulatory Authority Inspections. Participate in Quality Management Review, Annual Product Review, Material Review Board, Quality Compliance Operational Committee and Recall Committee activities, as needed. Aid in the Validation efforts, projects, and action items including validations of: Process; Facilities, Utilities, Equipment (FUE), Shipping and Cleaning. Ensure compliance with applicable laws, regulations and guidelines for Travere Therapeutics' contract manufacturing organizations. Draft and revise QA controlled documents. Review and approve GxP related documents, as requested. Track deliverable progress versus timelines and goals. Ensure appropriate record-keeping. Provide, facilitate retrieval of, and review relevant regulatory submissions, as requested. Education / 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 considered. Minimum 8 years of experience in Biotech or Pharmaceutical industry working in an FDA regulated industry in QA or a related field. Minimum of 5 years of Quality Assurance auditing experience preferred. Additional Skills / Experience: The ideal candidate will embody Travere's core values: Patient-Inspired, Courageous, Promote Community, and Stronger Together. In-depth knowledge of and ability to interpret and apply GxP, FDA and ICH regulations and guidelines. Proven ability in driving GxP process improvement initiatives. Experience with Microsoft based applications and ability to learn internal electronic applications/systems. Experience with eQMS systems (e.g., VEEVA) is a plus. Strong professional experience in a similar role within the pharmaceutical industry, both small and large molecule pharmaceuticals. Well organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment. Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity. Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer.
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Department: 107100 Quality 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 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/projects. Serve 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 management. Manage internal/external day-to-day Quality issues as they arise. Aid in the development, update, implementation, and management of supplier Quality Agreements. Manage and provide support of the Quality System activities including product/process deviations, validation, and Batch Record Review. Proactively identify and mitigate key cross-functional and vendor issues independently with limited need to escalate. Serve as the Person-In-Plant activities for assigned initiatives/projects Suppliers, as necessary. Support vendor management oversight while effectively resolving issues escalated from the project teams. Proactively and effectively communicate within Quality Assurance and other appropriate functions regarding the development, progress, activities, and results for assigned responsibilities. Support Regulatory Authority Inspections. Participate in Quality Management Review, Annual Product Review, Material Review Board, Quality Compliance Operational Committee and Recall Committee activities, as needed. Aid in the Validation efforts, projects, and action items including validations of: Process; Facilities, Utilities, Equipment (FUE), Shipping and Cleaning. Ensure compliance with applicable laws, regulations and guidelines for Travere Therapeutics' contract manufacturing organizations. Draft and revise QA controlled documents. Review and approve GxP related documents, as requested. Track deliverable progress versus timelines and goals. Ensure appropriate record-keeping. Provide, facilitate retrieval of, and review relevant regulatory submissions, as requested. Education / 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 considered. Minimum 8 years of experience in Biotech or Pharmaceutical industry working in an FDA regulated industry in QA or a related field. Minimum of 5 years of Quality Assurance auditing experience preferred. Additional Skills / Experience: The ideal candidate will embody Travere's core values: Patient-Inspired, Courageous, Promote Community, and Stronger Together. In-depth knowledge of and ability to interpret and apply GxP, FDA and ICH regulations and guidelines. Proven ability in driving GxP process improvement initiatives. Experience with Microsoft based applications and ability to learn internal electronic applications/systems. Experience with eQMS systems (e.g., VEEVA) is a plus. Strong professional experience in a similar role within the pharmaceutical industry, both small and large molecule pharmaceuticals. Well organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment. Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity. Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer.
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