Curium Quality Operations Manager New Products in Maryland Heights, Missouri
Hiring multiple positions at various levels based on experience and education level... ABOUT Company : Company was formed in 2017 through the union of IBA Molecular and Mallinckrodt Nuclear Medicine LLC. Company is a world-class nuclear medicine solutions provider with over 100 years of combined industry experience. We are proud to service over 14 million patients worldwide each year and strive to provide best-in-class quality products and exceptional, reliable service. Our diverse group of industry experts is unified under one strong and singular focus to develop, manufacture and supply SPECT, PET and therapeutic radiopharmaceuticals to customers around the globe. In fact, we have over 6,000 customers in over 70 countries world-wide. At Company , every single dose counts in helping doctors and patients diagnose and treat disease. That means every single employee counts toward meeting this unified objective to help each patient live Life Forward . We have an amazing team that lives by our core values every single day integrity, commitment and collaboration. Our North American headquarters is in Maryland Heights, MO. Come grow with us! SCOPE OF POSITION: The Quality Operations Manager - New Products will work in a dynamic organization in the Project Support Group PSG for North America. This role has the responsibility for supporting and implementing projects related to Company s business strategy in the space of sterile drug manufacturing including reactor and cyclotron derived new products. This role will help support activities associated with BDandL, MandA, PMO, and CMO activities. Projects can include technical transfer, drug development, conceptual design, scoping and estimation, integration, etc. The Quality Operations Manager - New Products will be responsible for working in collaboration with RandD, project engineering, quality assurance, quality control, validation, and manufacturing through all phases of projects from concept evaluation through commercial product launch. ESSENTIAL FUNCTIONS: * Support large cross-functional projects and project teams through Subject Matter Expert quality compliance guidance in process evaluation, design, and implementation of processes * Provide cGMP, Regulatory, and Validation guidance in evaluation of new products within existing or new manufacturing equipment and clean room manufacturing areas * Partner with RandD, Manufacturing, Quality, Engineering, and Maintenance to develop applicable SOP s, Batch Records, and Training Documents. * Define requirements for and generate project validation plans * Estimate quality and validation project activities to provide accurate cost and schedule targets * Manage project quality assurance and validation activities and resources * Generate, execute , and manage protocols * Work collaboratively with Project Manager to quickly move projects from scoping to implementation * Partner with Quality Leadership to ensure good quality and cGMP practices and their implementation in new product launch The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. EQUAL OPPORTUNITY EMPLOYER: Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.Employer's Job# 1179Please visit job URL for more information about this opening and to view EOE statement.