Associate Director, Quality Assurance Technical

Department:

Location:

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 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 - Technical is responsible for leading and providing GxP Analytical quality/compliance support and/or oversight as per requirements and applicable guidance. This role works closely with the cross functional Travere team and Traveres contract vendors for testing of product for clinical and commercial use.

Responsibilities:

• Lead and support analytical qualification validation and transfer of analytical methods for small and large molecules.
• Review approve and/or oversee various aspects of analytical validation activities including but not limited to:
  • Method Validation Protocol
  • Raw Data Review
  • Method Validation Report
  • Test methods
• Serve as the primary point of contact for Travere cross functional groups and contract vendors for analytical questions issues and resolution of:
  • Laboratory Deviations
  • Out of Specification / Out of Trend Results
  • Change Controls
  • CAPA
• Provide subject matter expertise in aiding risk assessment activities to appropriately assess the impact on product quality while supporting mitigation recommendations for the above.
• Support product(s) stability program with review and approval of protocols interim reports raw data review and final reports.
• Support the analytical review of data for regulatory submissions.
• Provide technical input to Travere Polices SOPs Work Instructions etc. assuring internal needs are defined while complying with Regulatory requirements Guidance and/or industry standards
• Maintain up-to-date knowledge of analytical regulatory requirements practices and processes (ex. FDA ICH EMA and USP requirements).
• Aid in the internal and external Quality audit function as needed
• Provide support and contribute to inspections audits and due diligence activities as needed.
• Support QA and Travere Senior Management with various projects as needed.

Education/Experience Requirements:

• Bachelors degree in life science or related field of study required. A relevant technical or scientific field Chemistry Biology or Chemical Engineering is preferred. Equivalent combination of education and applicable job experience may be considered.
• 8 years of experience in an analytical function supporting drug/biologics development and commercialization in the biotechnology or pharmaceutical industry required.
• Direct experience in GMP Quality Assurance Analytical Qualification/Validation and/or Quality Systems.
• Broad knowledge of cGMPs (CFR/ICH) and applicable international regulations and guidelines.

Additional Skills/Experience:

• The ideal candidate will embody Traveres core values: Courage Community Spirit Patient Focus and Teamwork.
• Demonstrated ability to critically assess/analyze information draw the appropriate technical conclusions based upon system knowledge influence approach and work effectively across different internal and external functions to resolve complex technical quality issues.
• Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.
• Adept problem-solving skills a strong sense of urgency keen attention to detail ability to work independently and be able to effectively manage multiple priorities in an environment under time and resource pressures.
• Ability to travel up to 10-20% domestic and international.
• All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote.

Total Rewards Offerings:
Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse equitable people-centric and pay-for-performance organization.

Benefits: Our benefits include premium health financial work-life and well-being offerings for eligible employees and dependents wellness and employee support programs life insurance disability retirement plans with employer match and generous paid time off.

Compensation: Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock) designed to recognize retain and reward employees.

Target Base Pay Range:

*This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidates experience education skills and location.

Travere will accept applications on an ongoing basis until a candidate is selected for the position.

Travere Therapeutics Inc. is an EEO/AA/Veteran/Disability Employer.

If you require a reasonable accommodation to complete the application or interview process please contact us by sending an email to . Please note that this email address is to be used exclusively to request an accommodation with the online application interview or hiring process only. Travere HR will not reply to emails sent to this address for any other reason.