Sr. Laboratory Auditor, Quality Assurance GLP

Travere Therapeutics • San Diego, CA

4d • $95,000 - $124,000 • Remote

About The Position

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.

Requirements

• 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
• 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 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.

Nice To Haves

• Auditor certification (e.g., ASQ-CQA, RQAP-GLP) is preferred but not required.
• Experience with eQMS systems is a plus.

Responsibilities

• 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.

Benefits

• 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
• generous paid time off
• combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level