Consultant, GxP Services
$71,000–$125,000 year
RemoteUnited States
United StatesRemoteFull Time$71,000–$125,000 yearMedium
Full TimeMedium
Job Summary
Conduct domestic and independent audits, assessments, and inspection readiness activities for pharmaceutical, biotechnology, and medical device clients. Perform mock inspections, support SOP reviews, and prepare documentation, reports, and observations under senior consultant direction. Deliver GxP consulting services across investigator sites, TMFs, vendors, and facilities while collaborating with project managers to meet timelines. Maintain current knowledge of GxP regulations and industry best practices. Requires 50-70% travel.
Required Qualifications
- 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
- Foundational knowledge of GCP and other applicable GxP regulations focused on investigator sites
Desired Qualifications
- 1-3 years of experience supporting GxP, QA, compliance, auditing, or operational functions
- Experience working within pharmaceutical, biotechnology, medical device, CRO, or related industries
- Spanish language skills – intermediate fluency
- 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
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