$165,495 – $235,620
Listed on Gilead Sciences’s own careers site. You apply with them directly — we never stand between you and the employer.
What this role is
This role leads quality assurance and regulatory inspection operations for a pharmaceutical manufacturing site, managing inspection readiness, compliance procedures, and digital quality systems. It suits experienced QA professionals in biotech or pharma who have managed regulatory agency interactions and can oversee complex inspection logistics across global operations.
Our summary, not Gilead Sciences’s wording. The full posting is on their site.
Skills this role names
- ISO 13485
- Machine Learning
- Microsoft Excel
- Microsoft PowerPoint
- Microsoft SharePoint
- Microsoft Teams
- Microsoft Word
- Zoom
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What they ask for
Required
- BS/BA in Biology, Sciences, or related field with 10+ years experience (or MS/MA with 8+ years, or PhD with 5+ years)
- Biotech or pharmaceutical industry experience
- Knowledge of 21 CFR Parts 4, 11, 203, 205, 210, 211, 600, 610, 820 and EudraLex Volume 4
- Knowledge of manufacturing and testing processes for APIs, oral solids, liquid formulations, biologics, aseptic fill/finish, and packaging
- Experience managing Health Authorities during regulatory inspections
- Experience managing partners during inspections
- Knowledge of audit processes and risk-based principles
- Leadership experience with team development and inclusion accountability
Nice to have
- Previous regulatory Health Agency investigator experience
- Experience with digital quality systems and analytics platforms
- Working knowledge of AI, machine learning, and advanced analytics in Quality and Compliance
- Experience supporting internal audits, site audits, and third-party audits