Overview
Remote
Depends on Experience
Contract - W2
Contract - Independent
Skills
Pharma SaaS environments
ICH GCP E6
Quality Auditing certification
Job Details
- 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.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.