Director Quality Assurance Quality Control

QA/QC Director - Fairfield, NJSummary:The QA/QC Director is primarily responsible for the development and implementation of quality management systems. Establishing quality standards and procedures as well as monitor compliance and regulatory requirements.ResponsibilitiesTo ensure that the production facility is operating at a high operational and compliance standard.Lead, coach and manage a team of chemists to ensure data integrity and performance to meet business objectivesMonitor each department's operations to ensure that all procedures are being adhered to and that only approved products or services are being delivered to the company's clients.Oversee the entire department, ensuring that proper procedures are being followed when approving each product or service.Ensure that deadlines are metTrain and develop colleaguesAssist employees to solve problems, using quality management techniquesConsult with the quality managers and other personnel to design quality strategies and goals for the department, which will be implemented by employeesHelp to promote the implementation of quality systems throughout the companyDevelop and implement policies relating to all operations in accordance with company objectives. Ensure these policies are adhered to by personnel under your supervision and that appropriate records are kept for future referenceKeep management informed on product quality and any concerns that may influence this measure, such as complaints from customers or suppliers, etceteraOther duties assigned by ManagementEducation:Bachelor's degree in a scientific discipline with a minimum of 10 years' experience in quality managementExperience Requirements: Experienced with liquid manufacturing and packaging of Rx products.Experience with Empower 3Experience working in an FDA regulated environmentExperience with ANDA and NDA submissionsExperience with validations of processes, cleaning, analytical methods, facilities and equipmentKnowledge of CFR & ICH Regulatory GuidelinesKnowledge of cGMP processes and GDP.Computer Skills:Microsoft WordMicrosoft ExcelEmpower 3Other Requirements:Has significant technical knowledge of quality management principles.In depth knowledge of all laboratory equipment, practices, and proceduresAbility to think logically and independentlyDemonstrated managerial abilitiesProblem analysis, solving and resolution skillsHas excellent oral and written skillsHas excellent interpersonal skillsIs self motivatedHas a very high attention to detailHas a positive attitudeMust speak, read, and write in English

Created: 2025-10-02