Director of Quality Assurance

About Us At cGMP Consulting, we specialize in providing expert validation, qualification, and compliance services to the life sciences industry. Our team works with clients to ensure their facilities, equipment, and processes meet regulatory standards, enabling the safe and efficient production of pharmaceuticals. cGMP Consulting is based in Lake Forest, IL. Position Summary cGMP Consulting is seeking an experienced and driven 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 role offers significant autonomy, leadership responsibility, and the opportunity to establish and scale a high-performing quality function in a fast-paced, GMP-compliant environment. The ideal candidate is a hands-on quality leader with proven experience building or leading QMS programs within regulated warehouse, distribution, pharmaceutical, healthcare, government, or government-contractor environments. This candidate has led multi-site quality programs, developed teams, and driven continuous improvement, and is equally comfortable leading investigations, audits, and validation activities as presenting quality risks and performance metrics to executives, customers, auditors, and government stakeholders. This position is remote. Candidates in or around the Houston, TX area are preferred, and travel of up to 50% is required. This is a direct-hire position. Responsibilities The essential functions include, but are not limited to the following: 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 to customer requirements, contractual obligations, and operational risks. Develop quality metrics, reporting, and management-review processes, providing leadership with visibility into quality performance, risks, and key decisions. Lead and develop site quality teams across multiple locations, driving consistent quality execution while empowering local teams to maintain 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 activities, including inventory accuracy, product integrity, chain of custody, and customer-owned inventory controls. Oversee quality requirements for ambient, refrigerated, frozen, and ultra-cold storage environments, including temperature mapping, environmental monitoring, equipment qualification, calibration, and requalification activities. Lead investigations of deviations, nonconformances, temperature excursions, alarm events, customer complaints, inventory discrepancies, and other quality events. Oversee root-cause analysis, corrective and preventive action (CAPA) programs, and effectiveness verification, monitoring open actions, risks, and escalations through resolution. Lead change control and continuous-improvement initiatives, including quality impact assessments 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, and represent the quality organization 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 all applicable company policies, training requirements, cGMP regulations, and safety standards. Support broader site and departmental initiatives through additional leadership tasks or assignments as designated by management. 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. 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, 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 Qualifications 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. Disclaimer The duties and responsibilities described are not a comprehensive list and additional tasks may be assigned to the employee from time to time; or the scope of the job may change as necessitated by business demands. All duties and responsibilities are subject to possible modification to reasonably accommodate individuals with disabilities. The requirements listed are the minimum levels of knowledge, skills, or abilities necessary to perform this job successfully. The company is an Equal Opportunity Employer, drug-free workplace, and complies with ADA regulations as applicable. #J-18808-Ljbffr cGMP Consulting Inc