Associate Director, Quality Assurance - Technical

Travere Therapeutics; Providence (RI); Hybrid; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics in San Diego, CA, is seeking an Associate Director of Quality Assurance - Technical to lead GxP analytical quality/compliance for testing of therapeutic products in clinical and commercial use. The role partners with cross-functional teams and contract vendors to ensure robust analytics.

The preferred candidate has 8+ years in analytical QA, a life sciences degree, and strong knowledge of CFR/ICH regulations.

Qualifications

• Bachelor's degree in life science or related field required; equivalent combination may be considered.
• 8+ years in analytical function supporting drug/biologics development and commercialization in biotech/pharma.
• 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.

Responsibilities

• Lead analytical qualification, validation and transfer of analytical methods for small and large molecules.
• Review and oversee analytical validation activities including method validation, raw data review, method validation report and test methods.
• Serve as primary point of contact for cross-functional groups and vendors for analytical issues and resolution of deviations or OOS/OOT results, change controls, CAPA.
• Provide SME in risk assessment to assess impact on product quality and mitigation recommendations.
• Support product stability programs with protocol/lab data review and final reports; contribute to regulatory submissions.

Skills

GxP Analytical quality

Analytical Qualification/Validation

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree in life science

8+ years in analytical function

Job description

Department: 107100 Quality

Location: San Diego, 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 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 Travere’s 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 Policies, 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

• Bachelor's 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 Travere's 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

$150,000.00 - $195,000.00

*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 candidate's experience, education, skills, and location.

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