Department:
107100 Quality
Location:
San Diego, USA- Remote
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 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: - 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 will accept applications on an ongoing basis until a candidate is selected for the position.
