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Manager, Quality Assurance

$136.34k - $176.44k

Gilead

Gilead Sciences seeks a Quality Assurance Manager to oversee compliance with regulatory requirements and manufacturing standards. The role involves supervising QA personnel, maintaining GMP/GLP processes, reviewing product quality data, and coordinating investigations and audits.

Responsibilities

  • Supervise QA personnel, organize tasks, conduct training, and write performance evaluations
  • Write or recommend changes to controlled documents to meet quality objectives
  • Review manufacturing, environmental monitoring, and quality control data for compliance
  • Conduct or coordinate investigations, CAPA recommendations, and compliance audits
  • Partner with R&D on new product launches and collaborate with contract manufacturers on compliance issues

Requirements

  • 7+ years GMP environment experience and bachelor's degree, or 5+ years experience with master's degree
  • Proficiency in GMPs and/or GLPs
  • Strong analytical and conceptual skills with ability to manage multiple priorities
  • Excellent verbal communication, technical writing, and interpersonal abilities
  • Knowledge of international quality systems regulations and Microsoft Office applications
  • Beneficial: Six Sigma, DMAIC methodology, risk management tools (HACCP, FMEA)

Compensation: $136,340–$176,440 base

Vacancy posted 5 days ago
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