RRemoteville
Gilead Sciences logoGilead Sciences

Associate Director, Quality Assurance Compliance

Skills
21 CFRCFRData IntegrityMedical DevicesMicrosoft WordOn SitePrevention
Role

What the job involves

The main requirements, responsibilities and hiring steps.

Requirements

  • BS/BA in Biology Sciences or related discipline with 10+ years relevant experience OR MS/MA with 8+ years OR PhD with 5+ years
  • Biotech or pharmaceutical industry experience required
  • Experience managing Health Authorities during inspections
  • Experience managing customer or business partners during inspections
  • Knowledge of domestic and global regulations including 21 CFR Parts 4 11 203 205 210 211 600 610 820 EudraLex Volume 4 GDP QMSR/ISO13485 Health Canada GMP/GDP ICH ISO and USP EP standards
  • Detailed knowledge of manufacturing and testing processes for APIs Oral Solid Drug Product Liquid Formulations Biologics Aseptic Fill Finish Primary and Secondary Packaging Medical Device and Warehousing Distribution
  • In-depth knowledge of audit process and risk-based principles
  • Excellent computer systems knowledge including Microsoft Word Excel PowerPoint MSTeams and Veeva Vault
  • Working knowledge of AI machine learning and advanced analytics as applied to Quality Compliance and Inspection Management
  • Experience using or supporting digital quality systems and analytics platforms to improve inspection outcomes
  • Understanding of AI governance principles including data integrity validation human oversight cybersecurity and privacy
  • Ability to translate complex data and AI-enabled insights into actionable inspection-ready narratives
  • Good leadership and organizational skills with ability to work independently
  • Effective communication skills in a matrix environment
  • Team player with excellent interpersonal skills

Nice to have

  • Strategic visionary
  • Credible resource
  • Strong organizer
  • Professional writer
  • Effective communicator
  • Matrix collaborator

Day to day

  • Manage logistics and coordination for regulatory inspections at GSI Foster City, including notification processes inspection support teams prep rooms and post-inspection follow-up
  • Build and maintain inspection readiness tools templates training materials and centralized resources to support perpetual readiness across site and global teams
  • Lead PAI readiness periodic mock inspections global best-practice sharing and continuous improvement initiatives while partnering with Quality IT Digital and cross-functional stakeholders

Hiring process

  • Submit application via Workday
  • Use ApplicantAccommodations@gilead.com for accommodations if needed