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Company

Travere Therapeutics · 11 hours ago

Senior Manager, QA Audit GCP/GLP/GVP

United States

Full-time

Remote

Senior Level, Lead/Staff

$120K/yr - $165K/yr

7+ years exp

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Comp. & Benefits

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Responsibilities

Serves as a GCP, GLP and GVP regulatory requirements and expectations expert.

Manages and/or supports Travere’s Development and Clinical audit program (internal and external), schedule(s)

Provide input and expertise to clinical vendor risk assessments in support of the Clinical Vendor/Service Provider Qualification Program.

Plan, conduct and manage audits of clinical vendors, clinical sites, and/or internal clinical processes, and associated follow-up activities, including documentation fully describing and accurately depicting the audit preparation, execution, and observations.

For audits conducted by external auditors, lead coordination and communication activities between internal stakeholders and auditors to ensure audits fulfill business needs.

Supports the maintenance and further development of Travere’s quality infrastructure, processes, and systems to drive compliance (including but not limited to regulatory compliance) of all Development and Clinical programs.

Supports the inspection readiness program and regulatory inspection management while providing input to inspection-related process improvement.

Develops and maintains Standard Operating Procedures (SOPs), Quality processes, documentation, guidelines, and support continual process improvements projects, as required.

Maintains up to date compliance training and current changes within Regulation and/or guidance.

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

Develops and delivers relevant Quality training across the business, as required.

Provides Quality Issue and Event Management Activities support for (e.g., SOP Deviation and CAPA), perform root cause analysis, and manage related actions plans until resolution, closure and if needed verification.

Review clinical documents (e.g., protocols, clinical study reports, informed consent forms, etc.) for compliance with regulations, regulatory guidelines, and SOPs.

Reviews quality data and develop analytics that can be used to identify trends, as needed.

Other duties as assigned by Quality Assurance Management.

Qualification

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GCP regulationsGLP regulationsGVP regulationsQuality Assurance auditingClinical ResearchEQMS systemsMS WordMS ExcelMS PowerPointMS OutlookAdobe

Required

Bachelor's degree in a scientific discipline is required.

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

4+ years of Quality Assurance auditing experience is required.

In-depth knowledge of and ability to interpret and apply GCP EU, FDA and ICH regulations and guidelines.

Strong working knowledge/experience in planning, conducting, and reporting clinical site and service provider audits.

Adept understanding of the GCP, GLP, and/or GVP audit process and associated Lead Auditor experience.

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

Robust knowledge of delivery of complex activities around governance, compliance, and risk management.

Self-motivated with a solid sense of ownership in areas of responsibility.

Highly developed organizational and leadership skills.

Excellent interpersonal, verbal and written communication skills.

Ability to manage multiple, complex tasks in a fast-moving environment.

Quick learner with the ability to independently plan, prioritize, multi-task and follow through on responsibilities.

Solution driven team player with a strong customer service approach.

Ability to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies.

Proficient computer skills including MS Word, Excel, PowerPoint, Outlook, and Adobe.

Ability to travel for training and auditing (approx. 30-50%) domestically and internationally.