Director, Quality Assurance (pharma) Category Biotech/pharmaceutical Location Redwood City, California
AdeptSource
Redwood City, California, US
Salary: + bonus + equity
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Develop and implement gxp quality systems
Review gxp documents and reports
Provide compliance oversight for gxp activities
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AdeptSource is seeking a hands-on Director of Quality Assurance for their biotech client in Redwood City, CA. The ideal candidate will have extensive experience in the biologics industry and a strong understanding of GXP regulations to ensure compliance and quality systems development.
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Job Summary
Develop and implement GXP quality systems in accordance with ICH, FDA, EMA and global competent authority regulations.
Provide quality oversight for GMP CDMOs and manage GMP product batch record review and disposition.
Lead and ensure inspection readiness activities for all internal and external entities and host GMP inspections.
Matching Summary
Match Score: 75
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AdeptSource is seeking a hands-on Director of Quality Assurance for their biotech client in Redwood City, CA. The ideal candidate will have extensive experience in the biologics industry and a strong understanding of GXP regulations to ensure compliance and quality systems development.
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Salary
Salary: plus bonus and equity
Skills & Requirements
Must-have
Develop and implement GXP quality systems
Review GXP documents and reports
Provide compliance oversight for GXP activities
Coordinate and perform audits
Host GMP inspections and manage CAPAs
Develop and implement quality management systems
Ensure GXP strategy and performance metrics
Nice-to-have
Hands-on approach
Collaborative work environment
Fast-paced small company environment
Tenacity to adjust workload
Key Requirements
Minimum of 10 years’ experience in a pharmaceutical setting
Bachelor’s degree in biological sciences or related field
Proven knowledge of worldwide GXP regulatory requirements
Experience interacting with and managing CMOs
Experience leading/hosting US and international health authority inspections