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Quality System Project Manager

Corning is one of the world's leading innovators in materials science. For more than 160 years, Corning has applied its unparalleled expertise in specialty glass, ceramics, and optical physics to develop products that have created new industries and transformed people's lives. Corning succeeds through sustained investment in R&D, a unique combination of material and process innovation, and close collaboration with customers to solve tough technology challenges. As a leading developer, manufacturer, and global supplier of scientific laboratory products for 100 years, Corning's Life Sciences segment collaborates with researchers seeking new approaches to increase efficiencies, reduce costs and compress timelines in the drug discovery process. Using unique expertise in the fields of materials science, surface science, optics, biochemistry and biology, the segment provides innovative solutions that improve productivity and enable breakthrough discoveries. Scope of Position: Corning is seeking a Division Quality System Project Manager, with experience in a regulated environment industry, to work on projects related to the quality system. You will lead multi-departmental, cross-functional teams which are focused on the delivery of new or existing projects associated with feature enhancements of the system. We look for you to also plan / develop and maintain associated project schedules while working on various tasks associated with the projects. Tasks include generating, executing and reviewing a variety of System Development Life Cycle documentation while following Corning's change control and validation processes.   Day to Day Responsibilities: Lead project teams to define and execute overall plans to meet project objectives. Drive the project's progress, from program Kick-off to Closure. Engage internal customers during each stage of project to keep them focused and informed. Support the Define and Development phases of projects by working withinternal customers on determining deliverables. Develop schedules/resource plans for project testing activities. Support and perform design and development testing assignments prior to qualification activities. Author and review validation lifecycle documents. Document types include but are not limited to validation plans, validation protocols, qualifications (IQ/OQ/PQ), summary and analysis of pertinent test data, validation summary reports, requirement/design specifications, traceability matrices, SOPs, work instructions and forms. Author and review validation deviation investigations to determine their impact on the system, process and product quality, the cause and corrective actions to preclude further deviations of a similar nature. Work on implementation activities associated with projects such as conducting training, performing implementation activities and cutover monitoring. Communicate project status and needs/risks to senior management. Align with all SOPs as documented in the Quality System. Drive department and site process improvements.   Travel Requirements: 20% domestic and international.   Hours of work/work schedule/flex-time: Monday-Friday, flex time, option to work remotely one day a week as projects allow.   Required Education: Bachelor's degree in Science, Engineering, Information Technology, or other related business field.   Required Years and Area of Experience: Minimum of 3 years of Quality Management system experience within a regulated environment (examples: biotechnology, pharmaceutical, medical device, Life Sciences).   Required Skills: Project leadership experience. Knowledge of and experience in process and software verification and validation activities.   Desired Experience / Qualifications / Skills: Project experienceassociated with software releases. EtQ software design and/or user experience. Experience conducting risk assessments using tools such as Process/Design Failure Mode and Effects Analysis (PFMEA /DFMEA). Experience with SQL and/or Python.   Soft Skills: Do you have excellent written and oral interpersonal skills and attention to detail? Effective skills in analytical thinking and problem solving are beneficial in this role. Can you influence within a peer group and higher management? Do you have the ability to work in teams and able to interact with individuals of all functions and levels to obtain results?   This position does not support immigration sponsorship. We prohibit discrimination on the basis of  race, color, gender, age, religion, national origin, sexual orientation, gender identity or expression, disability, or veteran status or any other legally protected status.
Salary Range: NA
Minimum Qualification
Less than 5 years

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