Quality System Manager

Role Description The Quality System Manager is a full-time position. This role oversees the development, implementation, and continuous improvement of the company’s quality management system to ensure compliance with internal standards, customer requirements, and applicable regulations. The Quality Manager is responsible for leading the implementation, deployment, and ongoing management of a new Quality Management System (QMS) for a packaging supplier supporting temperature-sensitive and cold chain shipments for pharmaceutical, biotech, and life sciences customers. This role will establish and maintain core quality system processes including document control, training management, corrective and preventive actions (CAPA), change control support, internal audits, and continuous improvement initiatives. Approximately 50% of the role will focus on supplier quality management, including supplier qualification, monitoring, audits, risk management, and performance improvement. The ideal candidate combines hands‑on QMS implementation experience with supplier quality expertise in regulated packaging, medical device, pharma, or cold chain environments. Qualifications Required Bachelor’s degree in Engineering, Quality, Life Sciences, Supply Chain, or related field. 5+ years of Quality Management experience in packaging, cold chain, pharmaceutical, medical device, or regulated manufacturing environments. Demonstrated experience implementing or significantly upgrading a Quality Management System. Strong knowledge of document control, training systems, CAPA, root cause investigation, and supplier Quality management. Experience with supplier qualification, audits, and supplier performance management. Working knowledge of ISO 9001 and quality management principles in regulated industries. Experience establishing Quality Control (QC) specifications and QC inspection/sampling plans for manufactured product. Experience supporting customer audits and third‑party audits. Strong project management, organizational, and cross‑functional leadership skills. Preferred Experience in packaging, cold chain packaging, insulated shippers, or logistics‑related quality systems. Knowledge of pharma cold chain requirements, GDP, and temperature‑sensitive packaging validation. Lead Auditor certification (ISO 9001 or similar). ASQ certifications such as CQE, CQA, or CMQ/OE. Experience with electronic QMS systems (eQMS platforms). Key Responsibilities QMS implementation and process design Supplier quality leadership Risk management and problem solving Root cause analysis (5 Why, Fishbone, FMEA, etc.) Audit readiness and compliance Cross‑functional influence Analytical skills, with ability to create scenarios modeling conceptual changes and performance scenarios. Attention to detail and maintenance of confidential information. Proven ability to translate strategic ideas and concepts into actionable plans and foster a team approach with assigned accountabilities and objectives. Ability to use available information to project or forecast potential future scenarios. Level of Experience 5+ years of related work experience Experience with implementing and/or managing a Quality Management System (QMS) #J-18808-Ljbffr Thermal Shipping Solutions