Manager, Quality Assurance
$136.34k - $176.44kGilead
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
$136.34k - $176.44k
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