Senior Manager, Quality Assurance
$157.59k - $203.94kGilead
Responsibilities
- Serve as global process owner for quality agreement program, ensuring compliance and consistent implementation
- Develop and maintain standardized quality agreement templates, guidance documents, and training materials
- Provide subject matter expertise on quality agreement content, interpretation, and applicability to internal and external stakeholders
- Drive alignment and resolution of complex quality agreement terms across legal, sourcing, and quality teams
- Establish governance processes, metrics, and reporting to ensure program transparency and effectiveness
Requirements
- 8+ years GMP environment experience with bachelor's degree, or 6+ years with master's degree, or 2+ years with PhD/PharmD
- Expertise in quality agreement development, negotiation, lifecycle management, and governance
- Strong knowledge of global regulatory requirements (FDA, EMA, ICH) applicable to quality agreements
- Advanced technical writing skills for drafting and standardizing quality agreement templates
- Cross-functional stakeholder management, influencing, and negotiation capabilities
- Experience managing complex, high-visibility programs with multiple concurrent deliverables
- Preferred experience with contract manufacturing organizations and regulatory authority interactions
Vacancy posted 22 days ago
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