Job Description
Piper Companies is seeking a Senior GCP (Clinical) Auditor / Compliance Specialist to support Quality Assurance activities for a clinical research organization. This is a full‑time, 100% remote position with approximately 15–20% domestic and international travel for clinical site audits. The ideal candidate is experienced in independently leading GCP audits and excels in a fast‑paced, collaborative environment while ensuring regulatory compliance across clinical trial operations.
Note: Candidates must have independently led GCP audits in a clinical environment. Experience limited to audit participation, audit readiness, or GLP‑only audits will not be considered. Candidates must live in Delaware, Maryland, Virginia or North Carolina during employment.
- Responsibilities of the Senior GCP Auditor / Compliance Specialist:
- Lead independent GCP audits of clinical trial sites to ensure compliance with regulatory requirements and industry standards.
- Support the development, implementation, and maintenance of the Quality Management System (QMS).
- Oversee key QA functions including training, document control, CAPA management, and complaint handling.
- Conduct internal audits and drive continuous improvement through quality metrics and performance monitoring.
- Review, update, and maintain QA‑controlled documentation to ensure alignment with current procedures and regulations.
- Support vendor and supplier audits and assist during regulatory inspections.
- Qualifications of the Senior GCP Auditor / Compliance Specialist:
- Bachelor’s degree required.
- Proven experience independently leading GCP audits in a clinical research environment (GCP experience required; GMP/GLP‑only experience not sufficient).
- Strong understanding of GCP regulations, regulatory audit processes, and quality systems within CRO environments.
- Excellent written and verbal communication skills.
- Proficiency with Microsoft Office applications.
- Compensation of the Senior GCP Auditor / Compliance Specialist:
- Salary Range: $80,000 – $110,000 per year, based on experience and certifications (open to associate‑ and specialist‑level candidates).
- Benefits: Comprehensive benefits package including Cigna Medical, Dental, Vision, and 401(k) through ADP.
This job opens for applications on 03/16/2026. Applications will be accepted for at least 30 days from the posting date.
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