Director of Quality Assurance

cGMP Consulting•Houston, TX

2d•Remote

About The Position

cGMP Consulting is seeking an experienced quality leader to build, implement, and continuously improve a Quality Management System (QMS) supporting government warehouse, distribution, and regulated logistics operations across multiple sites. This senior-level position offers autonomy, leadership responsibility, and the opportunity to establish and scale a quality function in a GMP-compliant environment. The role is remote, with candidates in or around Houston, TX preferred, and requires travel of up to 50%. It is a direct-hire position. The Director leads multi-site quality programs and teams, oversees quality systems and operational controls, and drives investigations, audits, validation activities, and continuous improvement. The role partners with operational and functional leaders and communicates quality performance, risks, and corrective-action progress to executives, customers, auditors, and government stakeholders.

Requirements

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.
At least 8 years of progressively responsible experience in quality assurance, quality systems, regulatory compliance, supplier quality, distribution quality, or operational quality.
At least 3 years of experience managing personnel or leading a quality function, program, or multi-site quality initiative.
Demonstrated experience designing, implementing, and continuously improving QMS, 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 environments.
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.
Strong executive communication, presentation, and stakeholder-management skills, sound judgment, and ability to drive issues through resolution.
Ability to obtain and maintain the security clearance required for supported programs.
Must be a U.S. citizen and able to satisfy contract-specific citizenship, site-access, suitability, and background investigation requirements.
Willingness and ability to travel up to 50%.

Nice To Haves

Hands-on cGMP experience supporting pharmaceutical, biotechnology, vaccine, medical-device, or public-health products in warehousing, distribution, cold-chain, validation, or quality-system environments.
Experience with federal logistics or government programs (e.g., SNS, HHS, DoD, VA, CDC, FEMA) or government-contractor experience.
Experience leading validation protocols, qualification studies, and regulated change-control programs.
ASQ certification (e.g., CQA, CQE, CMQ/OE), Lean Six Sigma certification, or comparable credential.
Master’s degree in a related field.
Active Secret security clearance.

Responsibilities

Build, implement, and continuously improve the QMS, including 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.
Develop quality metrics, reporting, and management-review processes to give leadership visibility into performance, risks, and decisions.
Lead and develop site quality teams across multiple locations, promoting consistent execution and local operational ownership.
Identify recurring issues, drive root-cause resolution, and ensure timely completion of corrective actions.
Establish quality controls across receiving, storage, inventory management, fulfillment, shipping, and transportation, including inventory accuracy, product integrity, chain of custody, and customer-owned inventory controls.
Oversee quality requirements for ambient, refrigerated, frozen, and ultra-cold storage, including temperature mapping, environmental monitoring, equipment qualification, calibration, and requalification.
Lead investigations of deviations, nonconformances, temperature excursions, alarm events, customer complaints, inventory discrepancies, and other quality events.
Oversee root-cause analysis, CAPA programs, and effectiveness verification; monitor open actions, risks, and escalations through resolution.
Lead change control and continuous-improvement initiatives, assess quality impacts of new sites, equipment, technologies, WMS enhancements, and process changes, and ensure required training is completed before implementation.
Lead internal audits and support customer, government, and external audits, inspections, and certifications; maintain audit documentation, corrective-action records, and controlled quality-system documents.
Oversee supplier qualification and approved supplier programs.
Serve as the senior quality partner to Operations, Compliance, Client Success, Engineering, IT, and program leadership; represent Quality in customer meetings, audits, inspections, and government reviews.
Translate customer, contractual, and regulatory requirements into sustainable operating procedures and quality controls.
Communicate quality performance, audit outcomes, investigations, risks, and corrective-action progress to leadership, customers, and government stakeholders.
Support significant quality incidents and participate in warehouse walkthroughs and site reviews.
Ensure adherence to company policies, training requirements, cGMP regulations, and safety standards.
Support broader site and departmental initiatives through additional leadership tasks or assignments designated by management.