Senior Quality Assurance Manager

Develop, implement, and manage the site Quality Management System (QMS) that aligns with industry standards and organizational objectives. Facilitate quality and continuous improvement initiatives to enhance operational efficiency, customer satisfaction, and overall performance. Lead all quality efforts at the plant to ensure that our products consistently meet or exceed defined quality standards and customer expectations. Collaborate with cross-functional teams to identify and implement quality improvements, drive process optimization, and achieve cost-effectiveness. Ensure timely resolution and closure of Corrective and Preventive Action (CAPA) plans. Conduct regular audits and assessments to evaluate the effectiveness of the QMS and processes, identifying areas for improvement. Analyze quality performance data and metrics to identify trends, develop insights, and drive data-driven decision-making. Establish and monitor key performance indicators (KPIs) to track the effectiveness and efficiency of quality processes and continuous improvement initiatives. Ensure site adheres to local regulations and industry standards for pharmaceutical packaging and printing. Provide training and mentorship to employees to enhance their understanding of quality principles, practices, and methodologies. Oversee supplier quality management, including supplier evaluations and audits, to ensure the quality of incoming materials and components. Represent the facility in dealings with external stakeholders related to quality and continuous improvement. Assist the Site leadership in driving a culture of quality excellence, continuous improvement, and accountability. This role will have supervisory responsibilities over the Quality Department, and it is expected that this individual will have previous experience leading successful teams. Other duties as assigned. Qualifications: Bachelor\'s degree in a related field (e.g., Quality Management, Engineering, Business Administration) is preferred. Minimum of 5 years of experience in quality management within the printing, packaging or pharmaceutical industries, with a proven track record of improving quality standards and processes. Knowledge of ISO 9001 (Quality Management Systems). Prior experience managing direct reports and leading teams to drive quality improvements and standardization efforts. Understanding of pharmaceutical industry regulations, including cGMP, FDA, and international quality standards. Strong analytical skills with the ability to analyze data, identify trends, and implement effective solutions. Excellent communication and interpersonal skills to lead and collaborate with cross-functional teams, direct reports, and stakeholders. Proficiency in quality management systems, data analysis tools, and software applications. QCBD Software Experience is a plus Relevant certifications such as Certified Quality Manager (CQM) or Certified Quality Auditor (CQA) are advantageous. Lean Six Sigma certification is a plus #J-18808-Ljbffr ClinLab Solutions Group