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.
The Senior Director, Quality Assurance-GMP ensures that the quality function maintains standards expected by global regulatory authorities, provides guidance and leadership on procedures for meeting regulations and promotes and enforces the expectations of the company for compliance. This position will assess risks and implement changes in regulatory guidelines to incorporate new, amended or future requirements for quality compliance, as well as monitor and support the implementation of efficiency and effectiveness measures. This position manages quality staff responsible for current Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and Quality Systems at Travere. This position is based in Travere's corporate headquarters in San Diego, CA.
The responsibilities include, but are not limited to the following quality functions that support both investigational and commercial operations:
- Provide Subject Matter Expert, Project, and direct support for Inspection Readiness Plans. Complete Inspection Readiness Plans, projects, workstreams, and action items. Ensure an inspection ready state is maintained.
- Ensure that Travere quality systems maintain the standards expected by global regulatory authorities for research, development, and commercial activities.
- Manage quality assurance staff, activities and functions.
- Manage and provide guidance on quality systems, including the implementation and maintenance of quality documentation.
- Define guidelines for quality risk assessments against regulatory compliance requirements for research and commercial GxP activities.
- Escalation point for quality authority review and interaction.
- On-going monitoring and management of quality system efficiencies.
- Assess opportunities to maintain compliance while streamlining quality operations.
- Lead the development, implementation, and continuous improvement of quality management systems (QMS).
- Qualification, oversight, and monitoring of quality at contract organizations.
- Provides guidance and assistance to the team during inspections, audits, and due diligence activities.
- Leads semi-annual management reviews and product reviews.
- Pro-actively and effectively communicates within Quality Assurance and R&D regarding the developments, progress, activities, and results for assigned responsibilities.
- Ability to independently manage vendors and third-party providers and effectively resolve issues escalated from the project teams.
- Pro-actively identifies and mitigates key cross-functional and vendor issues independently with limited need to escalate.
- Prepares and delivers status updates to senior management and executive management as needed.
- Exhibits leadership behaviors by setting high standards and goals for one's self and direct reports.
- Contributes to the development of the Quality Assurance function by initiating and driving positive change with the oversight of new initiatives, systems or directives for ongoing process improvement and implementation of best practices.
- A Bachelor's degree in a scientific discipline is required. An advanced degree is preferred. Equivalent combination of education and applicable job experience may be considered.
- A minimum of 12 years of experience in a GxP pharmaceutical environment is required. 15+ years of experience strongly preferred. A minimum of 10 years of management experience in a regulated pharmaceutical environment is required.
- Experience developing and implementing Inspection Readiness Plans, projects, workstreams, and activities.
- Experience in an FDA regulated environment is required.
- The ideal candidate will embody Travere's core values: Courage, Community Spirit, Patient Focus and Teamwork.
- Experience with EMA regulated environment is strongly preferred.
- Direct, hands-on experience interacting with regulatory health authorities at pre- and post approval inspections.
- Working knowledge of cGMP (CFR/ICH), GDP, and applicable international regulations and guidelines.
- Experience with implementing and maintaining pharmaceutical quality systems.
- Self-motivated with a solid sense of ownership in areas of responsibility.
- Highly developed organizational and leadership skills.
- Excellent interpersonal, verbal and written communication skills.
- Ability to manage multiple, complex tasks in a fast-moving environment.
- Ability to objectively observe processes and/or situations and interpret compliance risks.
- Detail oriented and the ability to handle frequent changes in product activity.
- Quick learner with the ability to independently plan, prioritize, multi-task and follow through on responsibilities.
- Solution driven team player with a strong customer service approach.
- Ability to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies.
- Proficient computer skills including MS Word, Excel, PowerPoint, Outlook, and Adobe.
- Ability to travel for training and auditing (approx. 30%) for domestic and international travel, if needed.
Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer