JBAndrews
Overview
Direct message the job poster from JBAndrews. Job title: Quality Manager. I am partnered exclusively with a Personal Care Contract Manufacturer in search for a Quality Manager. The ideal candidate is a critical thinker who will proactively improve the quality systems of the company through internal audits and participation in process improvement programs. This individual will oversee all aspects of quality systems, regulatory compliance and product release across manufacturing operations. We are looking at onboarding this position by the end of 2025. *Must be USA applicant. Must have
7+ years of QA/QC experience in personal care, cosmetics, OTC, or pharmaceutical manufacturing. Minimum 3 years experience in a leadership role. Bachelor’s degree in Chemistry, Biology, Engineering, or related scientific field; advanced degree preferred. Deep knowledge of FDA, Health Canada, ISO, and cGMP regulations. Proven experience managing audits, regulatory inspections, and customer compliance programs. Strong leadership, communication, and problem-solving skills with the ability to train and develop high-performing teams. Proficiency with ERP and quality management systems (e.g., ABAS, Visual, MasterControl, or equivalent). Ability to balance compliance with operational efficiency. Responsibilities
Develop, implement, and maintain quality management systems in compliance with FDA 21 CFR Parts 210/211, MOCRA, ISO standards, and cGMP requirements. Lead cross-functional QA/QC teams across laboratory and production operations to ensure compliant batch record review, deviation investigations, and timely product release. Oversee testing activities for raw materials, in-process, and finished products to verify adherence to internal and regulatory specifications. Manage internal and external audits, including FDA, UL, NSF, and customer audits, ensuring audit readiness, hosting, CAPA development, and timely closure of findings. Establish and monitor key quality metrics such as OOS, complaints, recalls, right-first-time, and first pass yield to drive data-based decision-making and continuous improvement. Collaborate with Operations, R&D, Regulatory Affairs, and Supply Chain to resolve quality challenges and support new product development and launches. Maintain and update SOPs, training programs, and documentation systems to ensure compliance and workforce competency. Drive continuous improvement initiatives including process validation, cleaning validation, risk assessments, and supplier quality management programs. Lead product complaint investigations, ensuring thorough root cause analysis and implementation of effective corrective and preventive actions. Support sustainability and environmental compliance initiatives aligned with carbon neutrality and responsible manufacturing goals.
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Direct message the job poster from JBAndrews. Job title: Quality Manager. I am partnered exclusively with a Personal Care Contract Manufacturer in search for a Quality Manager. The ideal candidate is a critical thinker who will proactively improve the quality systems of the company through internal audits and participation in process improvement programs. This individual will oversee all aspects of quality systems, regulatory compliance and product release across manufacturing operations. We are looking at onboarding this position by the end of 2025. *Must be USA applicant. Must have
7+ years of QA/QC experience in personal care, cosmetics, OTC, or pharmaceutical manufacturing. Minimum 3 years experience in a leadership role. Bachelor’s degree in Chemistry, Biology, Engineering, or related scientific field; advanced degree preferred. Deep knowledge of FDA, Health Canada, ISO, and cGMP regulations. Proven experience managing audits, regulatory inspections, and customer compliance programs. Strong leadership, communication, and problem-solving skills with the ability to train and develop high-performing teams. Proficiency with ERP and quality management systems (e.g., ABAS, Visual, MasterControl, or equivalent). Ability to balance compliance with operational efficiency. Responsibilities
Develop, implement, and maintain quality management systems in compliance with FDA 21 CFR Parts 210/211, MOCRA, ISO standards, and cGMP requirements. Lead cross-functional QA/QC teams across laboratory and production operations to ensure compliant batch record review, deviation investigations, and timely product release. Oversee testing activities for raw materials, in-process, and finished products to verify adherence to internal and regulatory specifications. Manage internal and external audits, including FDA, UL, NSF, and customer audits, ensuring audit readiness, hosting, CAPA development, and timely closure of findings. Establish and monitor key quality metrics such as OOS, complaints, recalls, right-first-time, and first pass yield to drive data-based decision-making and continuous improvement. Collaborate with Operations, R&D, Regulatory Affairs, and Supply Chain to resolve quality challenges and support new product development and launches. Maintain and update SOPs, training programs, and documentation systems to ensure compliance and workforce competency. Drive continuous improvement initiatives including process validation, cleaning validation, risk assessments, and supplier quality management programs. Lead product complaint investigations, ensuring thorough root cause analysis and implementation of effective corrective and preventive actions. Support sustainability and environmental compliance initiatives aligned with carbon neutrality and responsible manufacturing goals.
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