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Director, GCP Quality Assurance
Job in
San Jose, Santa Clara County, California, 95199, USA
Listed on 2026-10-09
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-10-09
Job specializations:
-
Quality Assurance - QA/QC
QA Specialist - Analyst/Manager, Regulatory Compliance Specialist, Quality Control - QC Analysts/Managers
Job Description & How to Apply Below
Role:
Lead GCP Quality Assurance for clinical development, overseeing audit activities to ensure compliance with global regulatory standards.
- 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
- 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
- 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
- GCP audit focus, clinical trial oversight, global regulatory compliance, experience with investigator sites and vendors.
remote with ability to travel overnight as needed; salary range $165,900—$207,400 USD.
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