Consultant, GxP Services

🕒 August 12

🇺🇸 United States – Remote

💵 $71k - $125k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

💼 Consultant

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Advarra

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 1983

🏥 Healthcare

💼 Consulting

☁️ SaaS

Healthcare • Consulting • SaaS

Advarra is a provider of integrated regulatory oversight and clinical trial technology, combining independent IRB review and compliance services with enterprise SaaS platforms (including Braid, OnCore, Clinical Conductor, eReg, and eSource). The company delivers operational intelligence, AI-powered protocol design and automation, site collaboration, study startup and enrollment tools, and strategic enablement services to sponsors, CROs, research sites, and institutions to improve efficiency, compliance, and patient safety across the clinical trial lifecycle.

📋 Description

• Support delivery of GxP consulting services for pharmaceutical, biotechnology, medical device, and life sciences clients • Assist with planning and conducting domestic audits and assessments under senior team direction • Plan and perform independent audits with subject matter expert support • Support inspection readiness activities as a co-auditor • Participate in mock inspections with senior consultants • Assist with SOP reviews and documentation • Develop subject matter knowledge over time • Support client communications with the project team • Participate in continuous improvement initiatives • Perform consulting engagements under direction • Participate in investigator site, TMF, vendor, facility, document, and systems audits • Prepare audit documentation, reports, observations, and supporting project deliverables • Assist with quality control reviews of project documentation and data • Support inspection readiness activities, mock inspections, and compliance assessments • Participate in SOP reviews, gap analyses, and quality system improvement initiatives • Assist with developing client training materials and participate in delivery of GxP-related training as appropriate • Collaborate with project managers and senior consultants to meet project timelines and client expectations • Maintain current knowledge of applicable GxP regulations and industry best practices • Support internal process improvement initiatives and perform other duties as assigned • Travel up to 50%–70%

🎯 Requirements

• Bachelor’s degree in Nursing, Life Sciences, or related field, or equivalent combination of education and experience • Minimum 3–5 years of experience in clinical research, quality assurance, regulatory compliance, or a related life sciences environment • Ability to travel extensively • 1–3 years of experience supporting GxP, QA, compliance, auditing, or operational functions • Experience in pharmaceutical, biotechnology, medical device, CRO, or related industries • Foundational knowledge of GCP and other applicable GxP regulations focused on investigator sites • Spanish language skills at intermediate fluency (preferred) • Demonstrated analytical and problem-solving skills • Strong written and verbal communication skills • Ability to manage multiple priorities while working collaboratively within project teams • Proficiency with Microsoft Office applications • Ability to sit or stand for extended periods at a stationary workstation • Ability to regularly carry, raise, and lower objects of up to 10 lbs. • Ability to learn and comprehend basic instructions • Focus and attention to tasks and responsibilities • Verbal communication skills, including listening, understanding, responding, and speaking

🏖️ Benefits

• Variable bonus eligibility • Health coverage • Paid holidays • Equal opportunity workplace committed to inclusion and respectful treatment • Professional development and continuous learning opportunities