Senior Manager, Quality Assay Validation

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the main Quality representative for the management of analytical methods throughout their lifecycle, aiding vaccine development initiatives.

• Ensure GMP quality oversight for activities related to the qualification, validation, transfer, verification, implementation, comparability assessments, and lifecycle management of analytical methods.

• Collaborate closely with teams in Analytical Development, Technical Operations, Regulatory Affairs, Supply Chain, and external laboratories.

• Facilitate product disposition decisions by reviewing analytical data, conducting investigations, and evaluating release testing results.

• Lead the quality aspects of assay validation, transfer, verification, comparability assessments, and lifecycle management.

• Oversee and approve validation protocols, reports, transfer documentation, analytical control strategies, specifications, and lifecycle records.

• Examine analytical data packages, certificates of analysis, laboratory investigations, and results from release testing.

• Approve deviations, investigations, CAPAs, change controls, OOS/OOT investigations, risk assessments, and analytical quality documentation.

• Assist with regulatory submissions, including analytical sections of BLA/MAA filings, responses to inquiries from health authorities, and preparation for inspections.

⛳️ Requirements

• A Bachelor’s degree or higher in a scientific field.

• Over 9 years of experience in GMP Quality, specifically in supporting analytical method validation, transfer, lifecycle management, and commercialization activities within the vaccine, biologics, or pharmaceutical sectors.

• In-depth knowledge of analytical method qualification, validation, transfer, comparability assessments, specifications, stability testing, and lifecycle management.

• Proven experience in supporting analytical readiness for process validation, PPQ, regulatory submissions, and commercialization efforts.

• Familiarity with health authority inspections, regulatory submissions, and addressing agency observations and inquiries.

• Practical knowledge of 21 CFR Parts 210 and 211, ICH Q2, ICH Q10, FDA analytical validation guidance, and global regulatory requirements.

• Preferred experience in supporting analytical sections of BLA, MAA, or similar submissions.

🏝️ Benefits

• Comprehensive medical, dental, and vision coverage.

• Flexible spending accounts.

• Flexible vacation and sick leave policies.

• Employer-sponsored life and disability insurance.

• 401(k) plan with employer matching contributions.

• Observance of 11 federal holidays.

• An extended winter break at the end of the year.