Curium Quality Operations Manager - New Products in Maryland Heights, Missouri
Hiring multiple positions at various levels based on experience and education level...
Curium was formed in 2017 through the union of IBA Molecular and Mallinckrodt Nuclear Medicine LLC. Curium 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 Curium, 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 Curium’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 BD&L, M&A, 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 R&D, project engineering, quality assurance, quality control, validation, and manufacturing through all phases of projects from concept evaluation through commercial product launch.
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 R&D, 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
Provide input to forecast estimates for project related costs and general project task tracking for adherence to project milestone goals
Generate and maintain quality risk assessments, including Failure Mode and Effects Analysis (FMEA)
Provide support for and manage preparation of documentation for regulatory filings
Bachelor Degree required; in Engineering or Sciences preferred
Five to seven years’ experience in quality assurance or validation roles in pharmaceutical manufacturing
Experience in pharmaceuticals desired but willing to consider other development areas such as medical device experience; aseptic manufacturing experience preferred
Strong project management and organizational skills, including ability to work independently and as a team member
Knowledge of regulatory requirements, and validation activities needed for manufacturing parenteral products
Verifiable working knowledge of cGMP regulations and guidelines. Application of cGMPs in an aseptic environment preferred
Familiar with project management tools and best practices
Experience applying formal Root Cause Analysis and problem solving methodologies
Proven ability in setting priorities and organizing work to meet deadlines
Technical understanding of the pharmaceutical development process from concept to launch; experience with stage gate processes for ANDA submissions preferred
Proven experience within complex multi-discipline project teams in a highly regulated environment
Strong oral and written communication skills with proven ability to communicate effectively in high pressure environments
Ability to react to problems and lead the team to develop solutions while communicating effectively to project leadership and stakeholders
Ability to maintain collaboration in a results driven environment
Agile approach and willingness to learn new things – ability to work “on the fly” in a dynamic setting
Advanced skills with Microsoft Office (Excel, PowerPoint, SharePoint, Word), MS Project and Visio
Travel may be required up to 10% of the time
Lean and/or Six Sigma certification preferred
Standard office environment, coupled with approximately 25% time in clean room, radiopharmaceutical manufacturing, and laboratory environments.
Must be willing to wear a variety of personal protective equipment.
Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
Responsibilities also include the ability to lift, walk, bend, stoop, push, pull, reach, and climb stairs without accommodation.
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.