Director of Quality Assurance

Job not on LinkedIn

🔥 4 minutes ago

🤠 Texas – Remote

🤠 Texas – Remote

⏰ Full Time

🔴 Lead

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 15%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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cGMP Consulting Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2001

🍽️ Food & Beverage

🏥 Healthcare

🏭 Manufacturing

Food & Beverage • Healthcare • Manufacturing

cGMP Consulting Inc. is a rapidly growing engineering and regulatory compliance firm that provides services to FDA regulated industries including pharmaceuticals, food, cosmetics, and medical devices. With a team of over 75 experienced engineers and consultants, the company specializes in current Good Manufacturing Practices (cGMP) compliance, including auditing, training, validation, and quality systems support. Their expertise ensures that clients remain compliant with industry standards and effectively implement new technologies.

📋 Description

• 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

• 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

• 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

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