Senior Manager, Quality Assay Validation

Reports to: Director Quality CMC

Location: Remote work, US Only 

Why Sabin: 

Our mission is to make vaccines more accessible, enable innovation and expand immunization across the globe. We seek a future free from vaccine-preventable diseases. We are an innovative, collaborative, and engaged team that values accountability, teamwork, partnership and driving impact. We are vaccine champions improving lives through immunization. Sabin staff, management, and the Board of Trustees are committed to ensuring that fairness, integrity, and opportunity remain at the core of how we operate.

Position Summary: 

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.

Key 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.

• 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. 

Other: 

• Subject to a criminal background investigation 
• Request for three professional references 
• Verification of education/degrees 

Sabin’s philosophy is to ensure fair, unbiased, equitable, competitive compensation and benefits. Using benchmarking and salary survey data, the annual salary for this position ranges from $120,000 - $148,000. The exact compensation may vary based on skills, experience, training, and certifications/degree. As a grant-funded organization, Sabin actively seeks funding for existing and new programs.

Sabin provides a comprehensive benefits package that includes medical, dental, and vision coverage, as well as flexible spending accounts. Eligible employees receive flexible vacation and sick leave, along with employer-paid life and disability insurance. The organization observes 11 federal holidays and an end-of-year winter break. Sabin also offers an employer-matching 401(k) plan.

Sabin is an Equal Opportunity Employer. All applicants will be considered for employment without attention to their race, color, religion, national origin, ancestry, age, disability or genetic information, sex (including gender identity, pregnancy or sexual orientation), marital status, veteran status, or any other characteristic protected by applicable federal, state or local laws.