Remote Global GCP QA Director: Audit & Compliance Leader

Acadia Pharmaceuticals; United States; A distancia; USD 166.000 - 207.000; Jornada completa

Descripción de la vacante

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.

Formación

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

Responsabilidades

• 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.

Conocimientos

GCP QA

Lead Auditor

Audit Management

ICH-GCP & FDA/EU regs

Educación

Bachelor’s in Life Sciences

Descripción del empleo

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.