Job Description
📋 Description Lead oversight of assay validation, method transfers, and lifecycle management. Review/approve validation protocols, reports, and control strategies. Partner with contract labs to ensure GMP compliance and quality performance. Evaluate data packages, COAs, investigations, and release results. Oversee stability programs, trend analyses, and documentation. Review deviations, CAPAs, change controls, OOS/OOT, and risk assessments. 🎯 Requirements 9+ years GMP QA in analytical method validation and lifecycle management (vaccines/biologics). Bachelor’s or advanced degree in a scientific discipline. Strong expertise in analytical method qualification, validation, transfer, comparability assessments, specifications, stability testing, and lifecycle strategies. Experience supporting readiness for process validation, PPQ, regulatory submissions. Experience supporting health authority inspections and regulatory filings. Working knowledge of 21 CFR Parts 210/211, ICH Q2, ICH Q10, FDA guidance. 🎁 Benefits Fully remote work opportunity for US-based candidates. Comprehensive medical, dental, and vision insurance coverage. Flexible spending account options. Flexible vacation and sick leave policies. Employer-matching 401(k) retirement plan. 11 observed federal holidays and an end-of-year winter break.
