Director of Quality Assurance

cGMP Consulting Inc.

. Build, implement, and continuously improve the QMS across government operations .

Posted 11/4/2026full-timeRemote • Texas • United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in Quality Management Systems (QMS) development and implementation, regulatory compliance, and supplier quality management within temperature-controlled environments. Proven ability to lead quality teams, conduct audits, and drive continuous improvement initiatives while ensuring adherence to cGMP regulations.

Highest-signal resume keywords

Quality Management Systems (QMS) DevelopmentRegulatory Compliance (cGMP)Supplier Quality ManagementRoot-Cause Analysis and CAPAExecutive Communication and Stakeholder Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality AssuranceQuality Metrics DevelopmentChange ControlDocument ControlTemperature MappingEquipment QualificationEnvironmental MonitoringISO 9001 PracticesAudit ManagementCAPA Programs

Soft Skills

LeadershipProblem-SolvingCommunicationPresentation SkillsJudgment

Tools & Technologies

Warehouse Management Systems (WMS)Quality Management Software

Certifications & Qualifications

ASQ CertificationLean Six Sigma Certification

Industry Keywords

PharmaceuticalBiotechnologyCold-Chain LogisticsGovernment ProgramsHealthcare

About the role

Key responsibilities & impact

Build, implement, and continuously improve the QMS 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
Lead and develop site quality teams across multiple locations
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
Oversee quality requirements for ambient, refrigerated, frozen, and ultra-cold storage environments
Lead investigations of deviations, nonconformances, temperature excursions, alarm events, customer complaints, inventory discrepancies, and other quality events
Oversee root-cause analysis, CAPA programs, effectiveness verification, open actions, risks, and escalations
Lead change control and continuous-improvement initiatives, including quality impact assessments of sites, equipment, technologies, WMS enhancements, and process changes
Lead internal audits and support customer, government, and external audits, inspections, and certifications
Oversee supplier qualification and approved supplier programs
Serve as senior quality partner to Operations, Compliance, Client Success, Engineering, IT, and program leadership
Represent the quality organization in customer meetings, audits, inspections, and government reviews
Translate customer, contractual, and regulatory requirements into 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

Requirements

What you’ll need

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
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
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, with sound judgment and the 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%
Preferred: hands-on cGMP experience supporting pharmaceutical, biotechnology, vaccine, medical-device, or public-health products
Preferred: experience with federal logistics or government programs or government-contractor experience
Preferred: experience leading validation protocols, qualification studies, and regulated change-control programs
Preferred: ASQ certification, Lean Six Sigma certification, or comparable credential
Preferred: Master’s degree in a related field and active Secret security clearance

Benefits

Comp & perks

Direct-hire position
Remote work arrangement
Opportunity to build and scale a high-performing quality function
Significant autonomy and leadership responsibility
Professional development through leadership of quality programs, audits, investigations, validation, and continuous-improvement initiatives