Shire Jobs

Department:107100 Quality

Location: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 Manager, QA Audit GCP/GLP/GVP is responsible for actively supporting the implementation of quality initiatives and for leading the execution of related activities. This position will assist with management of the audit program and partner with key clinical and cross-functional groups to ensure compliance of Travere's Clinical Development Programs and continuous process improvement.

Responsibilities: The responsibilities include, but are not limited to the following quality functions that support both investigational and commercial operations:

Serves as a GCP, GLP and GVP regulatory requirements and expectations expert.

Manages and/or supports Travere's Development and Clinical audit program (internal and external), schedule(s)

Provide input and expertise to clinical vendor risk assessments in support of the Clinical Vendor/Service Provider Qualification Program.

Plan, conduct and manage audits of clinical vendors, clinical sites, and/or internal clinical processes, and associated follow-up activities, including documentation fully describing and accurately depicting the audit preparation, execution, and observations.

For audits conducted by external auditors, lead coordination and communication activities between internal stakeholders and auditors to ensure audits fulfill business needs.

Supports the maintenance and further development of Travere's quality infrastructure, processes, and systems to drive compliance (including but not limited to regulatory compliance) of all Development and Clinical progr

Supports the inspection readiness program and regulatory inspection management while providing input to inspection-related process improvement.

Develops and maintains Standard Operating Procedures (SOPs), Quality processes, documentation, guidelines, and support continual process improvements projects, as required.

Maintains up to date compliance training and current changes within Regulation and/or guidance.

Promote compliance and quality throughout the company and represent the Quality Department in internal meetings and events.

Develops and delivers relevant Quality training across the business, as required.

Provides Quality Issue and Event Management Activities support for (e.g., SOP Deviation and CAPA), perform root cause analysis, and manage related actions plans until resolution, closure and if needed verification.

Review clinical documents (e.g., protocols, clinical study reports, informed consent forms, etc.) for compliance with regulations, regulatory guidelines, and SOPs.

Reviews quality data and develop analytics that can be used to identify trends, as needed.

Other duties as assigned by Quality Assurance Management.

Education/Experience Requirements:

Bachelor's degree in a s ientific discipline is required. Advanced degree is preferred. Equivalent combination of education and applicable job experience may be considered.

7+ years in drug/biologics development in the biotechnology or pharmaceutical industry. Minimum 5 years previous GCP Quality Assurance experience in Clinical Research and Development is preferred.

4+ years of Quality Assurance auditing experience is required.