Senior Manager, Quality Assay Validation
New
J
JobgetherBiopharmaceuticals
Fully remote work opportunity for candidates located in the United States.Full-TimeManager
Salary120,000 - 148,000 USD per year
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Job Details
- Experience
- 9+ years of GMP Quality experience
- Required Skills
- Quality Assurance
Requirements
- Bachelor’s degree or advanced degree in a scientific discipline.
- 9+ years of GMP Quality experience supporting analytical method validation, transfers, and lifecycle management.
- Proven experience within vaccines, biologics, or pharmaceutical development environments.
- Expertise in analytical method qualification, validation, transfer, comparability assessments, and stability testing.
- Experience supporting analytical readiness for process validation, PPQ, and commercial manufacturing.
- Experience supporting health authority inspections and regulatory filings (e.g., BLA, MAA).
- Working knowledge of 21 CFR Parts 210 and 211, ICH Q2, ICH Q10, and FDA analytical validation guidance.
- Strong communication, collaboration, and stakeholder management skills.
- Ability to travel occasionally based on business needs.
Responsibilities
- Lead quality oversight for assay validation, analytical method transfers, verification activities, comparability assessments, and lifecycle management.
- Review and approve validation protocols, reports, transfer documentation, analytical control strategies, and lifecycle management records.
- Partner with contract laboratories to ensure GMP compliance, effective investigations, and quality performance monitoring.
- Evaluate analytical data packages, certificates of analysis, laboratory investigations, and release testing results.
- Provide oversight of stability programs, trend analyses, and analytical quality documentation.
- Review and approve deviations, CAPAs, change controls, OOS/OOT investigations, and risk assessments.
- Support analytical readiness for technology transfers, process validation, PPQ campaigns, and regulatory filings.
- Contribute to regulatory submissions, agency interactions, inspection readiness, and supplier audits.
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