GCP Auditor Consultant (Remote)

About the role

Design Space InPharmatics, the North American division of Product Life Group, is seeking an experienced GCP Auditor Consultant to work remotely on a project‑basis. You will lead global GCP audits, support Health Authority inspections, and act as a key liaison between audited sites and the Quality Management System team.

Key responsibilities

• Plan, conduct and report GCP audits for investigator sites, TMF, CRO/vendor qualification and system audits, classifying findings by risk level.
• Prepare, facilitate and follow‑up on Health Authority inspections, including response development.
• Analyze audit KPIs, liaise with the QMS team and advise on corrective and preventive actions (CAPA).
• Develop audit programs, interact with QMS project members and manage outsourcing activities such as RFP reviews and subcontractor planning.
• Produce comprehensive audit reports with CAPA recommendations related to trial conduct and data integrity.

Required profile

• Advanced scientific degree (Pharm D or MSc) with specific Quality Assurance training preferred.
• 7–10 years of experience in quality assurance, including GCP audit conduct.
• Strong knowledge of global GCP regulations (ICH E6) and GVP, and up‑to‑date awareness of industry trends.
• Previous experience within pharmaceutical companies.
• Fluent English; additional languages are a plus.

Required skills

• GCP audit execution
• Regulatory compliance (ICH E6, GVP)
• CAPA development and implementation
• Quality Management System (QMS) liaison
• Audit reporting and KPI analysis

What we offer

• Fully remote, flexible consulting engagements.
• Opportunity to work on multiple concurrent projects with leading pharma clients.