Senior Manager, Quality Assay Validation

About the role

The Senior Manager, Quality – Assay Validation serves as the primary Quality representative for analytical method lifecycle management supporting vaccine development programs from clinical development through late-stage development, PPQ readiness, licensure preparation, and commercialization. The role provides GMP quality oversight for analytical method qualification, validation, transfer, verification, implementation, comparability assessments, and lifecycle management activities conducted at external contract laboratories. This position partners closely with Analytical Development, Technical Operations, Regulatory Affairs, Supply Chain, and external laboratories to ensure analytical methods support product characterization, control strategy development, release testing, stability programs, process validation, PPQ, and future commercial manufacturing. The role also supports product disposition decisions through review of analytical data, investigations, and release testing results. The successful candidate will possess broad analytical quality expertise, experience supporting late-stage development programs, regulatory submissions, BLA/MAA readiness, and health authority inspections while ensuring analytical systems, processes, and documentation remain compliant, robust, and inspection ready.

Responsibilities

• Lead the quality function for assay validation, transfer, verification, comparability assessments, and lifecycle management supporting vaccine clinical development, PPQ, and commercialization readiness.
• Provide quality oversight and approval of validation protocols, reports, transfer packages, analytical control strategies, specifications, and lifecycle documentation.
• Partner with contract laboratories to ensure GMP compliance and effective management of investigations, change controls, quality metrics, and performance trends.
• Review analytical data packages, certificates of analysis, laboratory investigations, and release testing results to support product disposition decisions.
• Review stability protocols, data packages, trend analyses, and shelf-life supporting data.
• Review and approve deviations, investigations, CAPAs, change controls, OOS/OOT investigations, risk assessments, and analytical quality records.
• Provide quality oversight for analytical readiness supporting technology transfers, process validation studies, and PPQ campaigns.
• Support regulatory submissions, analytical sections of BLA/MAA filings, responses to health authority questions, and inspection readiness activities.
• Participate in supplier qualification activities, audits, regulatory inspections, PAI readiness activities, and CAPA implementation associated with testing laboratories.

Requirements

• Bachelor's or advanced degree in scientific discipline.
• 9+ years of GMP Quality experience supporting analytical method validation, transfer, lifecycle management, and commercialization activities in vaccines, biologics, or pharmaceuticals.
• Strong understanding of analytical method qualification, validation, transfer, comparability assessments, specifications, stability testing, and lifecycle management.
• Demonstrated experience supporting analytical readiness for process validation, PPQ, regulatory submissions, and commercialization activities.
• Experience supporting health authority inspections, regulatory submissions, and responses to agency observations and questions.
• 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 submissions preferred.
• Occasional travel required to support organizational alignment and business needs.

Pay

$120,000 - $148,000 annually. The exact compensation may vary based on skills, experience, training, and certifications/degree.

Benefits

• Medical, dental, and vision coverage, as well as flexible spending accounts.
• Flexible vacation and sick leave, along with employer-paid life and disability insurance.
• 11 federal holidays and an end-of-year winter break.
• Employer-matching 401(k) plan.