Consultant, GxP Services

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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 consultants in delivering 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 • 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 compliance assessments, gap analyses, and quality system improvement initiatives • Assist with developing client training materials and participate in GxP-related training delivery • Collaborate with project managers and senior consultants to meet timelines and client expectations • Maintain current knowledge of applicable GxP regulations and industry best practices • Support internal process improvement initiatives and perform other assigned duties

🎯 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 preferred • Experience in pharmaceutical, biotechnology, medical device, CRO, or related industries preferred • Foundational knowledge of GCP and other applicable GxP regulations focused on investigator sites preferred • Intermediate Spanish language fluency preferred • Analytical and problem-solving skills • Strong written and verbal communication skills • Ability to manage multiple priorities 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 up to 10 lbs. • Ability to learn and comprehend basic instructions • Focus and attention to tasks and responsibilities • Verbal communication, listening and understanding, responding, and speaking

🏖️ Benefits

• Variable bonus eligibility in addition to base salary • Health coverage • Paid holidays • Equal opportunity workplace committed to an inclusive and collaborative environment • Professional development and continuous learning opportunities