GCP Quality Consultant - Remote for Biotech & Pharma

Widler & Schiemann AG; Princeton (NJ); On-site; USD 110,000 - 170,000; Full time

Job summary

Widler & Schiemann, LLC is a fully remote GCP Quality Consultant role serving biotech and pharmaceutical clients. You will audit vendors, internal processes, and investigator sites while acting as a trusted advisor on clinical development and pharmacovigilance projects.

You will plan audits, contribute as a subject matter expert across regulatory areas, and translate complex requirements into practical, scalable quality solutions for our clients. Travel is possible on an as-needed basis.

Qualifications

• 3-5 years of experience in a GCP environment
• Hands-on clinical research or clinical quality experience (e.g., CRA, Clinical Project Manager, QA Auditor)
• Demonstrated hands-on audit experience - you have conducted audits, not just supported them] ,
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Responsibilities

• Plan and conduct GCP audits - vendors, internal processes, and investigator sites
• Serve as a subject matter expert on clinical quality and compliance consulting projects
• Interpret and apply ICH GCP, GVP, FDA, and EMA requirements
• Conduct gap assessments, risk evaluations, and inspection readiness activities
• Support clients in managing deviations, CAPAs, and quality events
• Contribute to development of quality systems, SOPs, and governance frameworks
• Provide advisory support to biotech clients on scalable, risk-based quality approaches
• Work directly with biotech and pharmaceutical clients from day one
• Stay current with industry trends, digital tools, and regulatory expectations

Skills

GCP audits

Clinical quality

Regulatory knowledge

Client relationships

Technical writing

Education

Bachelor's degree in life sciences

GCP/GVP/CSV training

Job description

Widler & Schiemann, LLC is a fully remote GCP Quality Consultant role serving biotech and pharmaceutical clients. You will audit vendors, internal processes, and investigator sites while acting as a trusted advisor on clinical development and pharmacovigilance projects.

You will plan audits, contribute as a subject matter expert across regulatory areas, and translate complex requirements into practical, scalable quality solutions for our clients. Travel is possible on an as-needed basis.