Negotiable
Outside
Remote
USA
Summary: Seeking an experienced R&D Quality Assurance Senior Specialist with over 5 years of Google Cloud Platform QA experience in pharma, biotech, or CRO environments. The role involves serving as a Quality Subject Matter Expert (SME) to support clinical studies, audits, CAPAs, and inspection readiness while ensuring compliance with FDA/ICH standards. The ideal candidate will demonstrate strong collaboration skills and proficiency in relevant tools and processes.
Key Responsibilities:
- Serve as a Quality SME supporting clinical studies, audits, CAPAs, and inspection readiness.
- Ensure compliance with FDA/ICH Google Cloud Platform standards.
- Collaborate with Clinical, Regulatory, and PV teams.
- Support regulatory inspections and audits.
Key Skills:
- 5+ years Google Cloud Platform QA experience.
- Proficiency with Veeva and TMF management.
- Strong collaboration skills across Clinical, Regulatory, and PV teams.
- Experience supporting regulatory inspections and audits.
Salary (Rate): undetermined
City: undetermined
Country: USA
Working Arrangements: remote
IR35 Status: outside IR35
Seniority Level: undetermined
Industry: Other
Duration: 8+ Months
Overview:
Seeking an experienced R&D Quality Assurance Senior Specialist with 5+ years of Google Cloud Platform QA experience in pharma/biotech/CRO environments. The ideal candidate will serve as a Quality SME supporting clinical studies, audits, CAPAs, and inspection readiness while ensuring compliance with FDA/ICH Google Cloud Platform standards.
Must Have:
- 5+ years Google Cloud Platform QA experience
- Proficiency with Veeva and TMF management
- Strong collaboration skills across Clinical, Regulatory, and PV teams
- Experience supporting regulatory inspections and audits