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EMD Millipore Corporation QA Manager API and Excipients Cluster in Saint Louis, Missouri

A career with Company is an ongoing journey of discovery: our 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. Company is a business of Merck KGaA, Darmstadt, Germany.less thanbr> Your Role:less thanbr> As the Quality Manager for the APIs, Excipients and Cell Media technology cluster you will be accountable for the coordination of quality assurance and Quality related activities in the cluster in connection with the respective business and operations units and ensuring that each of the manufacturing sites have programs in place to meet regulatory and quality compliance relevent to the product claims, site registration and Life Science requirements.less thanbr> Responsibilities include:less thanbr> * Develops and implements programs to establish and maintain quality standards of existing products and services, as well as developing programs to focus employees on quality improvement. Implements policies, procedures and methods to check product, material, components and/or operational quality and improve same.less thanbr> * Provides direction through managers to execute functional business plans and contribute to the development of quality strategy.less thanbr> * Business partner for Site Heads of Quality focusing on the quality status and performance of the Operations site network by supporting the development a culture of quality and continuous improvementless thanbr> * Ensures quality of products, services and suppliers in compliance with external regulations and customer quality requirementsless thanbr> * Contributes to the future direction and quality strategy for the cluster sectorless thanbr> * Responsible for supporting day-to-day management, setting objectives, coaching and developing employees.less thanbr> * Supports negotiations and influences stakeholders internally and support the Quality Services team who interact with strategic customers for quality requirements, incident handling and quality performance, and support interaction with authorities as required by the regulatory managementless thanbr> * Engage and support the resolution of complex or unusual business problems applying advanced analytical thought and judgment.less thanbr> * Ensures site inspection readiness.less thanbr> * Reviews requests for major changes and PDP/TDP gate reviews and makes recommendations.less thanbr> * Support the initiation and review quality improvement plans.less thanbr> * Lead and manage critical quality incidents, interact with authorities with the support of the regulatory teamless thanbr> * Supports the governance to the local Quality Unit, site manager, cluster head to ensure quality of products, services and suppliers in compliance with external regulations and customer quality requirements.less thanbr>Who You Are:less thanbr>Minimum Qualifications:less thanbr> * Bachelor's degree in a scientific discipline or related discipline and/or certification in Quality Management or related area required.less thanbr> * Highly conversant in GMP requirments and knowledge of Regulatory agencies practices and guidelines.less thanbr> * Minimium of 5+ years of successful experience in a quality leadership role capacity with successful demonstration of the key responsibilities as presented above. Previous life science industry is preferred.less thanbr>Preferred Qualifications:less thanbr> * Demonstrated experience working in a highly matrixed, GMP manufacturing setting.less thanbr> * Demonstrated leadership, people development and coaching.less thanbr> * Requires prior managerial auditing experienceless thanbr> * Strong written and verbal communication skills.less thanbr> * Strong problem solving skills.less thanbr> * Strong computer skills, including word processing, and Quality system

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