Manager, Quality Assurance
New
R
RezoluteBiopharmaceutical
Redwood City / RemoteFull-TimeManager
Salary not disclosed
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Job Details
- Experience
- Five to seven years’ experience
- Required Skills
- SharePointMicrosoft OfficeQuality Assurance
Requirements
- Bachelor’s degree in a scientific discipline.
- 5-7 years of experience in a cGMP regulated pharmaceutical/biotech environment.
- Strong knowledge of Quality Systems and cGMPs (FDA, EU, ICH).
- Ability to assess compliance risks.
- Demonstrated ability to work independently and remotely.
- Strong technical writing and verbal communication skills.
- Ability to work collaboratively with cross-functional teams.
- Experience with Microsoft Office.
Responsibilities
- Review and approve Master Production Records and executed records from CMOs for Drug Substance and Drug Product operations.
- Perform final Product Disposition for clinical trials, extended access programs, and commercial supply.
- Provide Quality oversight for commercial packaging, distribution qualifications, validations, and serialization.
- Author and revise quality system SOPs and work instructions.
- Review and approve deviations, CAPA, change controls, and labeling/artwork for clinical and commercial products.
- Support inspection readiness, regulatory responses, and ongoing commercial process monitoring.
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