Senior Manager, Quality Assay Validation

The Senior Manager, Quality Assay Validation is responsible for ensuring analytical methods and testing systems meet regulatory, GMP, and commercialization requirements. Key responsibilities include:

1. Lead quality oversight for assay validation, analytical method transfers, verification activities, comparability assessments, and lifecycle management across development and commercialization programs.
2. Review and approve validation protocols, reports, transfer documentation, analytical control strategies, specifications, and lifecycle management records.
3. Partner with contract laboratories to ensure GMP compliance, effective investigations, quality performance monitoring, and continuous improvement.
4. Evaluate analytical data packages, certificates of analysis, laboratory investigations, and release testing results to support product disposition decisions.
5. Provide oversight of stability programs, trend analyses, shelf-life supporting data, and analytical quality documentation.
6. Review and approve deviations, CAPAs, change controls, OOS/OOT investigations, risk assessments, and related quality records.
7. Contribute to regulatory submissions, agency interactions, inspection readiness activities, supplier qualifications, audits, and corrective action implementation.

Requirements

• Extensive GMP Quality experience in analytical method validation, transfers, lifecycle management, and commercialization activities within vaccines, biologics, or pharmaceutical development.
• Strong expertise in analytical method qualification, validation, transfer, comparability assessments, specifications, stability testing, and lifecycle strategies.
• Demonstrated experience supporting analytical readiness for process validation, PPQ activities, regulatory submissions, and commercial manufacturing preparation.
• Experience supporting health authority inspections, regulatory filings, and responses to agency questions or observations.
• Working knowledge of 21 CFR Parts 210 and 211, ICH Q2, ICH Q10, FDA analytical validation guidance, and global regulatory expectations.
• Experience supporting analytical sections of BLA, MAA, or equivalent regulatory submissions is preferred.
• Strong communication, collaboration, problem-solving, and stakeholder management skills.
• Ability to travel occasionally based on organizational and business needs.

Benefits

• Competitive annual salary range of $120,000 - $148,000, with compensation determined based on skills, experience, training, and qualifications.
• Fully remote work opportunity for candidates located in the United States.
• Comprehensive medical, dental, and vision insurance coverage.
• Flexible spending account options.
• Flexible vacation and sick leave policies.
• Employer-paid life and disability insurance.
• Opportunity to contribute to initiatives focused on improving global access to vaccines and public health outcomes.