# Associate Director, Quality Assurance Compliance

Hiring organization: [Gilead Sciences](https://career.thegoodapps.co/organizations/gilead-sciences)

Canonical page: https://career.thegoodapps.co/jobs/a3957479-6ed2-40db-9675-663b1a5baa00

Listed on Gilead Sciences's own careers site. Applications go to them directly.

- Employment type: full time
- Seniority: Senior
- Salary: 165495 – 235620 USD per year

## Summary

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._

## Skills named

ISO 13485, Machine Learning, Microsoft Excel, Microsoft PowerPoint, Microsoft SharePoint, Microsoft Teams, Microsoft Word, Zoom

## 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

Apply on Gilead Sciences's site: https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---Foster-City/Associate-Director--Quality-Assurance-Compliance_R0051167-2