Senior Director, Quality Control – Program Implementation Lead

Sabin Vaccine Institute

. Establish Sabin’s first dedicated QC capability .

Posted 10/23/2026full-timeRemote • United StatesSenior💰 $216,000 - $243,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in establishing and overseeing Quality Control (QC) frameworks compliant with cGMP standards, including analytical method lifecycle management and vendor oversight. Proven ability to lead cross-functional teams and manage external laboratory relationships while ensuring regulatory compliance and quality assurance.

Highest-signal resume keywords

Quality Control Framework DevelopmentAnalytical Method Lifecycle ManagementGMP ComplianceRisk-Based Decision-MakingVendor Oversight

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Applicant Tracking System Keywords

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Hard Skills

Analytical TestingMethod TransferQualification/ValidationStability TestingOOS/OOT InvestigationsData IntegrityRegulatory SubmissionsQuality AgreementsSpecifications ManagementPPQ Readiness

Soft Skills

Problem-SolvingCommunicationLeadershipCollaborationAdaptability

Industry Keywords

Pharmaceutical QCBiopharmaceuticalCMCGMP EnvironmentOutsourced DevelopmentFederal Agency ProgramsBARDAQuality SystemsContinuous ImprovementCross-Functional Teams

About the role

Key responsibilities & impact

Establish Sabin’s first dedicated QC capability
Design and implement a phase-appropriate, current Good Manufacturing Practice (cGMP)-compliant QC framework supporting Phase 2 through Phase 3, PPQ, BLA, and commercialization
Establish the QC operating model, governance, processes, technical standards, and interfaces for drug substance and drug product testing
Collaborate with CMC leadership, CMC Quality, Analytical Sciences, Regulatory, Program Management, external laboratories, and CDMOs
Define QC roles, decision rights, handoffs, documentation requirements, and escalation pathways
Establish and maintain governance and sponsor oversight of laboratories and CDMOs
Support phase-appropriate QC strategies and standards aligned with product development, control strategy, regulatory requirements, and commercialization objectives
Oversee analytical method lifecycle management, specifications, release and stability testing, reference standards, critical reagents, investigations, and inspection readiness
Provide sponsor-level oversight of analytical PPQ readiness and validated in-process, release, characterization, and stability methods
Oversee method transfer, qualification/validation, implementation, lifecycle management, and technical support
Provide technical leadership and risk-based decision-making for analytical and QC issues
Review QC readiness and testing documentation supporting PPQ batches
Lead significant OOS/OOT results, deviations, data integrity concerns, and other QC-related quality risks
Ensure quality agreements define testing, data review and transfer, records retention, audit access, investigations, change notification, reference standards, sample management, stability activities, and escalation responsibilities
Ensure external QC activities are qualified, controlled, monitored, and aligned with GMP requirements, quality agreements, data integrity expectations, and regulatory commitments
Oversee vendor performance, testing activities, QC documentation, investigations, changes, and significant-risk escalation
Establish and maintain QC procedures and quality systems supporting outsourced testing
Support regulatory and US Government submissions, audits, and inspections by ensuring QC data and records are complete, accurate, traceable, reviewed, and consistent
Serve as QC representative on CMC and cross-functional program teams
Integrate QC requirements, dependencies, risks, and deliverables into program planning
Develop and evolve Sabin’s outsourced QC capability, external laboratory/CDMO relationships, technical expertise, systems, governance, and future organizational needs
Establish performance metrics and governance mechanisms to assess external QC network effectiveness, identify risks, and drive continuous improvement
Perform other duties as assigned

Requirements

What you’ll need

Bachelor’s degree in chemistry, biochemistry, pharmaceutical sciences, biology, life sciences, or a related scientific discipline
14+ years of progressive experience in pharmaceutical/biopharmaceutical QC, analytical sciences, CMC, or a closely related GMP environment
Experience supporting late-stage development and/or commercial manufacturing
Experience supporting USG-funded vaccine or biologics development programs, including BARDA or another federal agency, preferred
Experience with analytical PPQ readiness, vaccine release and stability testing, sponsor oversight of external testing laboratories, and preparing or reviewing QC data for regulatory submissions strongly preferred
Familiarity with quality agreements, contract deliverables, integrated schedules, risk registers, and change-control processes in an outsourced development and manufacturing environment preferred
Demonstrated experience overseeing outsourced QC activities, analytical laboratories, CDMOs, CROs, or other external testing organizations within a GMP environment
Strong knowledge of GMP QC principles, analytical method lifecycle management, method transfer, qualification/validation, specifications, stability and release testing, OOS/OOT investigations, data integrity, and inspection readiness
Demonstrated ability to establish QC governance and oversight within a virtual or matrixed organization and manage technical relationships with external partners
Strong risk-based decision-making, problem-solving, and communication skills
Ability to address unexpected QC issues and communicate technical risks to scientific, quality, regulatory, manufacturing, executive, and external partner audiences
Ability to lead through ambiguity and changing program needs
Experience in both development/start-up and commercial GMP environments strongly preferred
Subject to a criminal background investigation
Request for three professional references
Verification of education/degrees
Must be authorized to work in the United States without employer sponsorship; position is not eligible for visa sponsorship

Benefits

Comp & perks

Medical, dental, and vision coverage
Flexible spending accounts
Flexible vacation leave
Sick leave
Short-term disability options
Long-term disability options
10 federal holidays
End-of-year winter break
Employer matching 401(k) plan