Senior Director, Quality Control – Program Implementation Lead

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $216k - $243k / year

⏰ Full Time

🟠 Senior

👔 Director

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Sabin Vaccine Institute

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1993

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

💰 $35M Grant on 2023-01

Healthcare • Consulting • Food & Beverage

Sabin Vaccine Institute is dedicated to improving global health by ensuring access to life-saving vaccines. The institute focuses on research and development of new vaccines for some of the world’s most pressing diseases, including cholera, HPV, malaria, Marburg, and Ebola. Through innovative programs and partnerships, Sabin aims to enhance immunization capacities and vaccine acceptance within communities, ultimately striving to make vaccination accessible to all, especially vulnerable populations.

📋 Description

• 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

• 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

• 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