Director of Quality Assurance

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

📋 Description

• Develop, execute, and enhance the Quality Management System (QMS) across government operations.

• Create site and program quality plans that align with customer expectations, contractual obligations, and operational risks.

• Formulate quality metrics, reporting mechanisms, and management-review processes.

• Guide and cultivate site quality teams across various locations.

• Recognize recurring challenges, drive root-cause analyses, and ensure the timely execution of corrective actions.

• Implement quality controls in areas such as receiving, storage, inventory management, fulfillment, shipping, and transportation.

• Supervise quality standards for ambient, refrigerated, frozen, and ultra-cold storage environments.

• Direct investigations into deviations, nonconformities, temperature excursions, alarm events, customer complaints, inventory discrepancies, and other quality incidents.

• Manage root-cause analysis, Corrective and Preventive Action (CAPA) programs, effectiveness verification, open actions, risks, and escalations.

• Spearhead change control and continuous-improvement initiatives, including assessing the quality impacts of sites, equipment, technologies, Warehouse Management System (WMS) enhancements, and process modifications.

• Conduct internal audits and assist with customer, government, and external audits, inspections, and certifications.

• Oversee supplier qualification and maintain approved supplier programs.

• Act as a senior quality partner to Operations, Compliance, Client Success, Engineering, IT, and program leadership.

• Represent the quality department in customer meetings, audits, inspections, and government evaluations.

• Convert customer, contractual, and regulatory requirements into operational procedures and quality controls.

• Relay quality performance, audit results, investigations, risks, and corrective-action updates to leadership, customers, and government stakeholders.

• Assist with significant quality incidents and engage in warehouse walkthroughs and site evaluations.

• Ensure compliance with company policies, training prerequisites, cGMP regulations, and safety standards.

• Contribute to broader site and departmental initiatives through additional leadership roles or assignments.

⛳️ Requirements

• Bachelor’s degree in Quality Management, Supply Chain, Logistics, Engineering, Life Sciences, Business, or a related discipline, or an equivalent combination of education, certifications, military experience, and directly relevant practical experience.

• 8+ years of progressively responsible experience in quality assurance, quality systems, regulatory compliance, supplier quality, distribution quality, or operational quality.

• 3+ years of experience managing personnel or leading a quality function, program, or multi-site quality initiative.

• Proven experience in designing, implementing, and continuously enhancing QMS, including audits, investigations, CAPA, change control, document control, training, quality metrics, and ISO 9001-aligned practices.

• Background in leading quality programs within warehouse, distribution, logistics, cold-chain, or temperature-controlled operations under cGMP-regulated, pharmaceutical, healthcare, government, or similarly stringent environments.

• Familiarity with temperature mapping, equipment qualification, calibration, environmental monitoring, alarm management, and temperature-excursion investigations.

• Experience supporting supplier quality, operational change control, system validation, and quality assessments of process, equipment, or technology changes.

• Strong executive communication, presentation, and stakeholder-management capabilities, coupled with sound judgment and the capacity to drive issues to resolution.

• Ability to obtain and retain the necessary security clearance for supported programs.

• Must be a U.S. citizen and meet contract-specific citizenship, site access, suitability, and background investigation requirements.

• Willingness and capability to travel up to 50%.

• Preferred: hands-on cGMP experience supporting pharmaceutical, biotechnology, vaccine, medical-device, or public-health products.

• Preferred: experience with federal logistics or government programs, or experience as a government contractor.

• Preferred: experience leading validation protocols, qualification studies, and regulated change-control programs.

• Preferred: ASQ certification, Lean Six Sigma certification, or a comparable credential.

• Preferred: Master’s degree in a related field and active Secret security clearance.

🏝️ Benefits

• Direct-hire position.

• Remote work arrangement.

• Opportunity to establish and scale a high-performing quality function.

• Significant autonomy and leadership responsibilities.

• Professional development through the leadership of quality programs, audits, investigations, validation, and continuous-improvement initiatives.