Senior Director, Quality Control – Program Implementation Lead

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop Sabin’s inaugural dedicated Quality Control (QC) function.

• Design and implement a phase-appropriate framework for QC that complies with current Good Manufacturing Practices (cGMP), supporting Phase 2 through Phase 3, PPQ, BLA, and commercialization.

• Establish the QC operating model, governance, processes, technical standards, and interfaces for testing drug substances and products.

• Collaborate with CMC leadership, CMC Quality, Analytical Sciences, Regulatory teams, Program Management, external laboratories, and Contract Development and Manufacturing Organizations (CDMOs).

• Define roles, decision-making rights, handoffs, documentation requirements, and escalation pathways for QC.

• Establish and maintain governance and oversight of laboratories and CDMOs.

• Support phase-appropriate QC strategies and standards that align with product development, control strategy, regulatory requirements, and commercialization goals.

• Oversee the lifecycle management of analytical methods, including specifications, release and stability testing, reference standards, critical reagents, investigations, and readiness for inspections.

• Provide oversight at the sponsor level for analytical PPQ readiness and validated in-process, release, characterization, and stability methods.

• Manage method transfer, qualification/validation, implementation, lifecycle management, and provide technical support.

• Offer technical leadership and make risk-based decisions regarding analytical and QC issues.

• Review documentation for QC readiness and testing that supports PPQ batches.

• Lead investigations into significant Out of Specification (OOS) and Out of Trend (OOT) results, deviations, data integrity concerns, and other QC-related quality risks.

• Ensure that quality agreements outline testing requirements, data review and transfer, record retention, audit access, investigations, change notifications, reference standards, sample management, stability activities, and escalation responsibilities.

• Ensure that external QC activities are qualified, controlled, monitored, and aligned with GMP standards, 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 that support outsourced testing.

• Assist with regulatory and US Government submissions, audits, and inspections by ensuring that QC data and records are complete, accurate, traceable, reviewed, and consistent.

• Act as the QC representative on CMC and cross-functional program teams.

• Integrate QC requirements, dependencies, risks, and deliverables into program planning.

• Develop and enhance Sabin’s outsourced QC capabilities, relationships with external laboratories/CDMOs, technical expertise, systems, governance, and future organizational needs.

• Establish performance metrics and governance mechanisms to evaluate the effectiveness of the external QC network, identify risks, and promote continuous improvement.

• Perform additional duties as assigned.

⛳️ Requirements

• Bachelor’s degree in chemistry, biochemistry, pharmaceutical sciences, biology, life sciences, or a related scientific discipline.

• A minimum of 14 years of progressive experience in pharmaceutical/biopharmaceutical QC, analytical sciences, CMC, or a closely related GMP environment.

• Experience in supporting late-stage development and/or commercial manufacturing.

• Preferred experience in supporting USG-funded vaccine or biologics development programs, including BARDA or another federal agency.

• Strongly 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.

• Familiarity with quality agreements, contract deliverables, integrated schedules, risk registers, and change-control processes in an outsourced development and manufacturing context is preferred.

• Demonstrated experience overseeing outsourced QC activities, including analytical laboratories, CDMOs, CROs, or other external testing organizations within a GMP framework.

• 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.

• Proven ability to establish QC governance and oversight within a virtual or matrixed organization and manage technical relationships with external partners.

• Strong skills in risk-based decision-making, problem-solving, and communication.

• Ability to address unforeseen QC issues and communicate technical risks to scientific, quality, regulatory, manufacturing, executive, and external partner stakeholders.

• Capability to lead through ambiguity and adapt to changing program needs.

• Strongly preferred experience in both development/start-up and commercial GMP environments.

• Subject to a criminal background investigation.

• Three professional references required.

• Verification of education/degrees necessary.

• Must be authorized to work in the United States without employer sponsorship; this 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.