Negotiable
Outside
Remote
USA
Summary: The Google Cloud Platform Auditor role focuses on ensuring compliance and quality assurance within the healthcare and pharmaceutical sectors, specifically related to SaaS platforms. The position requires extensive experience in auditing and regulatory knowledge, particularly in Google Cloud Platform environments. The auditor will assess third-party vendors and work closely with clinical teams to validate outputs against regulatory expectations. Strong communication skills and relevant certifications are essential for success in this role.
Key Responsibilities:
- Assess third-party SaaS providers for compliance with contractual and regulatory obligations.
- Conduct detailed audits, prepare reports, and evaluate CAPAs.
- Work with clinical teams to validate outputs against medical/regulatory expectations.
- Maintain strong expertise in ICH Google Cloud Platform E6, FDA, EMA, HIPAA, and 21 CFR Part 11.
- Utilize knowledge of CDISC, MedDRA, and HL7 as needed.
Key Skills:
- Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or a related field.
- Minimum 10+ years in Healthcare/Pharma QA, including 7+ years in Google Cloud Platform audit.
- Quality Auditing certification (e.g., ISO 9001, ASQ CQA) or equivalent.
- Excellent written and verbal communication skills.
- Proven ability to interact effectively across all organizational levels.
Salary (Rate): undetermined
City: undetermined
Country: USA
Working Arrangements: remote
IR35 Status: outside IR35
Seniority Level: undetermined
Industry: IT
- Education: Bachelor s degree in Life Sciences, Pharmacy, Chemistry, or a related field.
- Experience: Minimum 10+ years in Healthcare/Pharma QA, including 7+ years in Google Cloud Platform audit (preferably in SaaS platforms).
- Vendor Audits: Ability to assess third-party SaaS providers for compliance with contractual and regulatory obligations.
- Regulatory Knowledge: Strong expertise in ICH Google Cloud Platform E6, FDA, EMA, HIPAA, 21 CFR Part 11, and global standards. Experience working with clinical teams to validate outputs against medical/regulatory expectations. Familiarity with CDISC, MedDRA, HL7 is a plus.
- Audit Skills: Proven ability to conduct detailed audits, prepare reports, and evaluate CAPAs.
- Certifications: Quality Auditing certification (e.g., ISO 9001, ASQ CQA) or equivalent.
- Soft Skills: Excellent written and verbal communication, able to interact effectively across all organizational levels.