Sr. Laboratory Auditor, Quality Assurance GLP

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 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 Sr. Laboratory Auditor, Quality Assurance GLP is responsible for actively supporting the implementation of GLP (e.g., Bioanalytical/Biomarker) initiatives and for leading the execution of quality related activities. In addition to the performance of laboratory audits, this position will assist with management of the audit program and partner with key clinical and cross-functional groups (e.g., Clinical Operations, Biometrics, Bioanalytical/Non-Clinical Development) to ensure the integrity of data generated for preclinical and clinical development programs and ensuring our contracted laboratories meet stringent pharma industry standards.

Essential Functions:

• Develop and implement risk-based audit strategies across clinical programs and/or studies with an emphasis on Bioanalytical studies to support Clinical and non-Clinical Bioanalytical Laboratory oversight.

• Plan, conduct and manage audits of pharmaceutical laboratories supporting nonclinical, clinical, and bioanalytical studies to ensure adherence to GLP/GCLP and relevant ICH guidelines.

• Evaluate laboratory systems including method validation, sample management, data integrity (ALCOA+ principles), equipment calibration/maintenance, and SOP compliance.

• Prepare comprehensive audit plans and reports, documenting findings, and recommendations for remediation. For those audits conducted by external auditors, lead coordination and communication activities between internal stakeholders and auditors to ensure audits fulfill business needs.

• Provide input and expertise to vendor risk assessments and qualification activities in support of GLP/GCLP Vendor/Service Provider Qualification Program.

• Identify, communicate, and escalate GLP/GCLP risks and serious non-compliance situations and follow to resolution, acting with an appropriate sense of urgency.

• Partner with internal stakeholders to manage vendor oversight and/or issue management.

• Conduct and/or facilitate investigations of GLP/GCLP Quality Events and collaborate with subject matter experts to conduct root cause analysis and to develop corrective and preventive action plans, as applicable.

• Manage and/or actively support the development, enhancement, review, and implementation of GLP quality standards and controlled documents (e.g., Policies, SOPs, Work Instructions, Templates)

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

• Build, develop and maintain working relationships with internal and external partners.

• Participate in the establishment of effective means for communicating audit and inspection outcomes, developing key metrics, measuring trends and driving improvements.

• Lead the development and delivery of laboratory quality and compliance related training to internal functions. This may include coordination efforts in training events delivered by Travere Internal Subject Matter Experts and/or external consultants.

• Provide GLP/GCLP guidance to internal stakeholders or Study Management Teams, as applicable.

• Participate in quality and/or cross-functional process improvement initiatives, as applicable.

• Stay up to date on GLP/GCLP compliance trends.

• Other duties as assigned by Quality Assurance Management.

Qualifications:

• Bachelor's degree in related Life Sciences discipline is required; advanced degree preferred. Equivalent combination of education and applicable job experience may be considered.

• 6+ years in drug/biologics development in the biotechnology or pharmaceutical industry.

• 5 years previous GLP Quality Assurance experience in Clinical and/or non-Clinical Research and Development is preferred.

• Minimum of 3 years of experience planning, conducting, and reporting GLP/GCLP audits within the pharmaceutical or biotechnology industry, including labs that conduct pharmacokinetics (PK), toxicology, clinical sample testing, and/or bioanalytical method development.

• Experience in supporting Research and Bioanalytical Groups in managing GLP Nonclinical Toxicology and/or Nonclinical/Clinical Bioanalytical Studies and/or providing oversight of service providers providing services and deliverables in these areas.

• In-depth knowledge and understanding of global regulations and guidelines including FDA 21 CFR Part 58, EMA GLP Directive, OECD Principles of GLP, MHRA GxP expectations, IVDR, and ICH guidance (e.g., Q2, E6).

• Demonstrated ability to define and implement procedures which ensure compliance to GLP/GCLP regulatory standards.

• Proven ability in driving GLP/GCLP process improvement initiatives

• Auditor certification (e.g., ASQ-CQA, RQAP-GLP) is preferred but not required.

• Strong working knowledge of computerized systems used in laboratories (e.g., LIMS, Chromatography Data Systems, ELNs) and relevant data integrity guidance (e.g., FDA Data Integrity Q&A).

• Experience with Microsoft based applications and ability to learn internal applications/systems. Experience with eQMS systems is a plus.

• Experience supporting lab operations in preclinical development through Phase 1-3 clinical trials.

• Ability to identify quality issues/discrepancies, and effectively and proactively manage, and resolve the issues/discrepancies in a diplomatic, flexible and constructive manner.

• Well organized with the ability to multitask, prioritize and manage shifting responsibilities in a dynamic, cross-functional teamwork environment.

• Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity.

• Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.

• Ability to travel 10-30% domestically and internationally.

• 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.

Travere is an EEO/AA/Veteran/Disability Employer

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 candidate's 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 accommodations@travere.com. 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.