Director, GCP Quality Assurance

Scorpion Therapeutics; United States; Remote; USD 166,000 - 207,000; Full time

Job summary

Scorpion Therapeutics is seeking a Lead GCP Quality Assurance professional to oversee clinical development audit activities ensuring global regulatory compliance. The role focuses on audits of CROs, investigator sites, and vendors, plus development of reports, quality agreements, and SOPs.

Ideal candidates bring a Bachelor’s in Life Sciences with 10+ years in pharma/biotech and 5+ years in GCP QA, including Lead Auditor experience.

Qualifications

• Strong knowledge of ICH-GCP, FDA and EU regulations.
• Experience auditing CROs, investigator sites, and vendors.

Responsibilities

• Manage internal and external GCP audits of CROs, investigator sites, and vendors.
• Develop audit reports, quality agreements, and SOPs.
• Support inspection readiness and regulatory inspections.
• Monitor GCP compliance metrics.
• Advise cross-functional teams on GCP regulations.
• Drive continuous improvement of quality systems.

Skills

GCP QA

Lead Auditor

Audit Management

ICH-GCP & FDA/EU regs

Education

Bachelor’s in Life Sciences

Job description

Role: Lead GCP Quality Assurance for clinical development, overseeing audit activities to ensure compliance with global regulatory standards.

Responsibilities

• manage internal and external GCP audits of CROs, investigator sites, and vendors
• develop audit reports, quality agreements, and SOPs
• support inspection readiness and regulatory inspections
• monitor GCP compliance metrics
• advise cross-functional teams on GCP regulations
• drive continuous improvement of quality systems

Requirements

• Bachelor’s in Life Sciences or related field
• 10+ years in pharmaceutical/biotech industry
• 5+ years in GCP QA, auditing, and compliance
• experience as a Lead Auditor
• strong knowledge of ICH-GCP, FDA, EU regulations
• experience with CRO/vendor audits and inspection support

Preferred

• SQA, ASQ, or Lead Auditor certification
• experience conducting global audits across US, EU, UK, Japan
• familiarity with clinical service providers such as eCOA, CSV, and data management

High Value

• GCP audit focus, clinical trial oversight, global regulatory compliance, experience with investigator sites and vendors.

Work Setup

remote with ability to travel overnight as needed; salary range $165,900—$207,400 USD.