- 8-10 years of hands-on Global Pharmacovigilance experience within biotech/pharma environments
- Proven track record supporting and leading FDA, EMA, and other global health authority inspections
- Confident interacting directly with regulators and managing regulatory inquiries
- Strong working knowledge of global GVP regulations and pharmaceutical quality standards
- Experienced in conducting internal audits and maintaining an effective, inspection-ready QMS
- Ensure global PV compliance (FDA, EMA, ICH)
- Lead risk-based PV audits, CAPA management, and metric trending
- Drive inspection readiness and serve as QA lead during health authority inspections
- Oversee PV deviations and maintain effective quality systems documentation
- Provide PV training, regulatory updates, and cross-functional compliance support
- Support EU QPPV, reporting activities, and product complaint oversight
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Senior Director Quality Assurance - Sunnyvale - Barrington James
Description
*****EXCITING NEW OPPURTUNITY ******
Director/ Senior Director - Quality Assurance
We are partnered with a global biotech that is looking to expand their quality team by bringing in a director/senior director of quality assurance.
Their position focus will be supporting the development, coordination and implementation of global pharmacovigilance regulations related to quality assurance activities.
Key requirements-
Responsibilities-
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Quality Assurance
Only for registered members Cupertino
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Quality Assurance
Full time Only for registered members Cupertino
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Quality Assurance
Only for registered members Cupertino, CA
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Quality Assurance
Only for registered members Cupertino, CA
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Quality Assurance Engineer
Only for registered members Sunnyvale
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Quality Assurance Engineer
Only for registered members Sunnyvale
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Quality Assurance Engineer
Only for registered members Sunnyvale
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Quality Assurance Architect
Only for registered members Sunnyvale
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Quality Assurance Tech
Only for registered members Sunnyvale
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Quality Assurance Tech
Only for registered members Sunnyvale
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Quality Assurance Architect
Only for registered members Sunnyvale, CA
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Quality Assurance Engineer
Alibaba Cloud- Sunnyvale
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Quality Assurance Engineer
Only for registered members Sunnyvale, CA
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Quality Assurance Tech
Only for registered members Sunnyvale
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Quality Assurance
Only for registered members Santa Clara
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Quality Assurance Tech
Only for registered members Sunnyvale, CA
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Quality Assurance Specialist
Only for registered members Sunnyvale
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Quality Assurance Specialist
Only for registered members Sunnyvale, CA
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Quality Assurance
Only for registered members San Jose, CA
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Quality Assurance Supervisor
Only for registered members San Francisco Bay Area
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Quality Assurance Manager
Only for registered members San Francisco Bay Area