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Corning Incorporated Project Manager, Quality/Regulatory in Tewksbury, Massachusetts

Project Manager, Quality/Regulatory

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Date: May 4, 2021

Location: Tewksbury, MA, US, 01876

Company: Corning

Requisition Number: 46040

Corning is one of the world’s leading innovators in materials science. For more than 160 years, Corning has applied its unparalleled expertise inspecialty 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 in a regulated environment industry, to work on projects related to the quality system. In this role, 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. You will also plan / develop and maintain associated project schedules while working on various tasks associated with the projects. We look for you to generate, execute and review 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 with internal 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 a variety of 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.

  • Comply with all SOPs as documented in the Quality System.

  • Proactively drive department and site process improvements.

Travel Requirements :

  • Up to 20%

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, Quality, Regulatory Affairs or other related business field.

Required Experience:

  • A minimum of 5+ years’ experience in a project management role.

Required Skills :

  • Project leadership experience.

  • Quality management system experience.

  • Working knowledge of FDA (food/beverage), medical device or pharmaceutical US or EU regulations.

Desired Skills :

  • Experience within a regulated environment (examples: biotechnology, pharmaceutical, medical device, Life Sciences).

  • Prefer PMP certification.

  • Project leadership experience associated with software releases.

  • Exposure to software design and/or user experience.

  • Experience conducting risk assessments using tools such as Process/Design Failure Mode and Effects Analysis (PFMEA /DFMEA).

  • Knowledge of and experience in process and software verification and validation activities.

Soft Skills:

  • Excellent written and oral communication skills.

  • Detail-oriented.

  • Ability to influence within peer group and higher management.

  • Ability to work in teams and able to interact with individuals of all functions and levels to obtain results.

  • Effective skills in analytical thinking and problem solving.

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, veteran status or any other legally protected status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Nearest Major Market: Boston

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