Quality Assurance Manager, Operations

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The company built on breakthroughs. Join us.

Corning is one of the world’s leading innovators in glass, ceramic, and materials science. From the depths of the ocean to the farthest reaches of space, our technologies push the boundaries of what’s possible.

How do we do this? With our people. They break through limitations and expectations– not once in a career, but every day. They help move our company, and the world, forward.

At Corning, there are endless possibilities for making an impact. You can help connect the unconnected, drive the future of automobiles, transform at-home entertainment, and ensure the delivery of lifesaving medicines. And so much more.

Come break through with us.

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.

Purpose of Position:

Manage and maintain the execution of Quality and Regulatory operations at Life Sciences manufacturing, sterilization, and distribution locations; including all related activities to ensure that the products meet applicable requirements. Promote continuous improvement in customer satisfaction through inter-department communication, internal manufacturing specification understanding, sharing information, leadership of quality improvement projects. This role is focused on delivery the highest quality product in the market at the lowest possible price by rigorous adherence to manufacturing requirements and effectively implementing cost of quality culture.

Key Responsibilities
:

• Manage and provide leadership to the quality departments within LS manufacturing locations to ensure products meet both customer expectations and all applicable regulatory requirements.
• Ensure sites have effectively implemented the division-level Quality System requirements; ISO 9001, ISO 17025, ISO 13485, and 21 CFR Part 820, as needed.
• Support receivership of the new product development process including plant resourcing, supplier/customer quality issue resolution for product realization.
• Drive department or regional program/ project portfolio to meet immediate and ongoing business needs including ongoing management of applicable resources.
• Frequently and effectively interact and resolve issues with peer-QARA leadership (i.e., team members) with little to no involvement from outside parties.
• Act as QARA integration point with manufacturing (Ops and engineering) for shared objectives and priorities.
• Effectively communicate impactful manufacturing issues/ actions with QARA peers to ensure all product, compliance, and customer needs are met.
• Coach and develop all direct employees to ensure they can effectively oversee production of conforming product in the spirit of customer obsession.
• Develop methods/metrics to evaluate and continuously improve process capability and product control plans; execute via collaboration with plant and division engineering.
• Provide oversight and ensure appropriate execution of the nonconforming materials program; ensure only highest quality parts are shipped to the customer using risk-based principles.

Education Required:

Bachelor’s Degree with technical discipline (e.g., Biology, Chemistry, Engineering, etc.) required; strong preference for candidates with an MBA or MS degree.

Experience and Skills

Minimum of 12 years’ experience in Quality Assurance or Regulatory with a minimum of 7 years in medical device/ biotech/ pharma.

Minimum of 5 years’ experience working in an active manufacturing environment.

Experience operating within regulated quality systems that are compliant with ISO 9001, ISO 13485, ISO 17025, and/ or 21 CFR Part 820, 210/211.

Demonstrated project management experience, including leading large-scale and/or multiple concurrent initiatives.

Minimu…