- 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 - Hayward - 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 Engineer
Only for registered members Hayward
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Coordinator, Quality Assurance
Only for registered members Hayward, CA
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Quality Assurance Technician
Only for registered members Hayward
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Quality Assurance Supervisor
Peoplework LLC- Hayward
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Quality Assurance Intern
Only for registered members Hayward, CA
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Coordinator, Quality Assurance
Only for registered members Hayward, CA
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Quality Assurance Supervisor
Full time Only for registered members Hayward
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Quality Assurance Manager
Full time Only for registered members San Leandro
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Quality Assurance Manager
Only for registered members San Leandro, CA
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Quality Assurance
Full time Only for registered members Newark
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Quality Assurance Manager
Only for registered members San Leandro
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Quality Assurance
Only for registered members Fremont
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Quality Assurance
Only for registered members Newark
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Quality Assurance
Only for registered members Fremont, CA
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Quality Assurance Manager
Only for registered members Union City, CA
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Director, Quality Assurance
Only for registered members San Leandro
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Quality Assurance
Only for registered members Newark, CA
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Quality Assurance Coordinator
Only for registered members San Leandro
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Quality Assurance
Only for registered members Fremont, CA
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Quality Assurance Coordinator
Only for registered members San Leandro, CA