Director of Quality Assurance

Cart.com•Washington, DC

10d•Remote

About The Position

Cart Government Solutions is establishing a dedicated quality function for its growing government warehouse, distribution, and regulated logistics operations. The Director of Quality Assurance is the senior quality leader responsible for building, implementing, and continuously improving a government-specific Quality Management System (QMS). The role leads quality across a multi-site network, establishing consistent standards and overseeing audits, investigations, corrective and preventive actions (CAPA), validation activities, and quality-system performance. The Director partners with Operations, Compliance, Client Success, Engineering, IT, and program leadership to strengthen accountability, mitigate risk, and support operational excellence. The role oversees quality controls for warehouse and distribution activities, including inventory accuracy, product integrity, chain of custody, customer-owned inventory, and ambient through ultra-cold storage. It also leads environmental monitoring, temperature mapping, equipment qualification, calibration, requalification, incident investigations, supplier quality, change control, and document control. The position serves as the senior quality partner to internal leaders and represents the quality organization in customer meetings, audits, inspections, and government reviews. It translates customer and contractual requirements into sustainable procedures and controls, communicates performance and risks to stakeholders, and develops site quality teams. The role may be based in or around Houston, Texas, though other U.S. locations are considered within the listed eligible states. Travel is up to 50%, depending on site support, audits, investigations, implementations, and customer needs.

Requirements

8 or more years of progressively responsible experience in quality assurance, quality systems, regulatory compliance, supplier quality, distribution quality, operational quality, or a related discipline.
3 or more years of experience managing personnel or leading a quality function, program, or multi-site quality initiative.
Demonstrated experience designing, implementing, maintaining, and improving QMS programs, including audits, investigations, CAPA, change control, document control, training, quality metrics, and ISO 9001-aligned practices.
Experience leading quality programs in warehouse, distribution, logistics, cold-chain, or temperature-controlled operations under cGMP-regulated, pharmaceutical, healthcare, government, or similarly rigorous conditions.
Experience 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.
Experience presenting quality metrics, audit findings, investigation outcomes, program risks, and corrective-action plans to leaders, customers, auditors, or government stakeholders.
Ability to translate customer, contractual, regulatory, and quality requirements into practical operating procedures.
Strong executive communication, presentation, stakeholder-management, and problem-solving skills, with sound judgment and the ability to drive issues through resolution.
Bachelor's degree in Quality Management, Supply Chain, Logistics, Engineering, Life Sciences, Business, or a related field, or an equivalent combination of education, certifications, relevant military experience, and directly related practical experience.
Ability to obtain and maintain the security clearance required for supported programs.
Must be a U.S. citizen and able to provide acceptable documentation verifying citizenship if selected.
Must satisfy applicable contract-specific citizenship, site-access, suitability, background investigation, and security requirements for supported programs.
Willingness and ability to travel up to 50%.
Must be available to support significant quality incidents and participate in warehouse walkthroughs and site reviews.

Nice To Haves

Hands-on cGMP experience supporting pharmaceutical, biotechnology, vaccine, medical-device, public-health, or similarly regulated products in warehousing, distribution, cold-chain, validation, or quality-system environments.
Experience building or transforming a QMS within a growing, evolving, or highly regulated organization.
Experience supporting federal logistics, Strategic National Stockpile (SNS), public-health distribution, HHS, DoD, VA, CDC, FEMA, or other government programs; military, federal agency, or government-contractor experience is highly valued.
Experience leading validation protocols, qualification studies, and regulated change-control programs.
ASQ certification, such as Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or a comparable credential.
Lean Six Sigma or another continuous-improvement certification.
Master's degree in a related field.
Active Secret Security Clearance.

Responsibilities

Build, implement, and continuously improve the government Quality Management System (QMS).
Establish quality policies, procedures, governance processes, and documentation standards across government operations.
Develop site and program quality plans aligned with customer requirements, contractual obligations, and operational risks.
Lead change-control and continuous-improvement initiatives and establish quality metrics, reporting, and management-review processes.
Provide leadership visibility into quality performance, risks, and key decisions.
Lead and develop site quality teams across multiple locations while promoting consistent execution and local operational ownership.
Identify recurring issues, drive root-cause resolution, and ensure corrective actions are completed on time and are effective.
Influence cross-functional teams to adopt quality standards, processes, and controls.
Establish quality controls for receiving, storage, inventory management, fulfillment, shipping, and transportation.
Oversee inventory accuracy, product integrity, chain of custody, and customer-owned inventory controls.
Investigate operational quality issues, customer complaints, and inventory discrepancies, and implement appropriate safeguards.
Oversee quality requirements for ambient, refrigerated, frozen, and ultra-cold storage environments.
Lead temperature mapping, environmental monitoring, equipment qualification, calibration, and requalification activities.
Ensure excursions, alarm events, and monitoring failures are investigated, documented, and resolved.
Partner with Facilities and Operations on inventory protection and business continuity plans.
Lead investigations into deviations, nonconformances, excursions, service failures, and other quality events.
Oversee root-cause analysis, CAPA programs, effectiveness verification, open actions, risks, and escalations.
Lead internal audits and support customer, government, and external audits, inspections, and certifications.
Maintain audit documentation, corrective-action records, and controlled quality-system documentation.
Partner with Compliance and operational leaders to address findings and improvement opportunities, and communicate outcomes and remediation plans.
Oversee supplier qualification and approved supplier programs.
Assess quality impacts of new sites, equipment, technologies, and process changes.
Review WMS enhancements and operational changes for validation, compliance, and quality-system impacts.
Ensure training is completed and documented before new processes or systems are implemented.
Represent the quality organization in customer meetings, audits, inspections, and government reviews.
Communicate quality performance, risks, investigations, and corrective-action progress to customers and government stakeholders.
Translate customer and contractual requirements into sustainable operating procedures and quality controls.
Support significant quality incidents and participate in warehouse walkthroughs and site reviews.