Senior Manager, Quality Assay Validation

📋 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.