Plant Quality Manager, Oneonta

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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.

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Corning’s businesses are ever-evolving to best serve our customers, industries, and consumers. Today, we accelerate and transform life sciences, mobile consumer electronics, optical communications, display, automotive, and solar markets. We are changing the world with:

• Trusted products that accelerate drug discovery, development, and delivery to save lives
• Damage-resistant cover glass to enhance the devices that keep us connected
• Optical fiber, wireless technologies, and connectivity solutions to carry information and ideas at the speed of light
• Precision glass for advanced displays to deliver richer experiences
• Auto glass and ceramics to drive cleaner, safer, and smarter transportation
• Solar polysilicon, wafers, and innovative photovoltaic modules, enabling low-cost solar energy solutions

Corning Life Sciences (CLS) is seeking a Plant Quality Manager to lead quality strategy, compliance, and continuous improvement at its Oneonta manufacturing facility. As a member of the Plant Leadership Team, this role is accountable for product and process compliance to regulatory, customer, and CLS standards — and for building a culture of quality across the plant. This is a high-impact leadership role with direct influence over plant safety, quality, service, and operational performance.

• Develop and lead the plant's strategic quality plan, ensuring compliance with ISO 9001, ISO 13485, 21 CFR Parts 820 and 211, USP, ASTM, cGMP, and GAMP 5 as applicable
• Serve as the plant Management Representative for Notified Bodies; lead and host regulatory authority and customer audits and inspections, and ensure effective, timely resolution of findings
• Oversee quality assurance and quality control functions, including testing of raw materials, in-process materials, finished goods, and critical facility utilities
• Partner with plant leadership, engineering, supply chain, finance, and divisional quality and regulatory functions to align on quality priorities and drive continuous improvement across the plant
• Lead, coach, and develop the plant quality organization; conduct Management Reviews in collaboration with the Plant Manager and execute strategic quality assurance projects aligned with business objectives

• Bachelor's degree in Life Sciences or Engineering
• 10+ years of related quality experience
• 5+ years of experience in a regulated manufacturing environment
• Prior supervisory or managerial experience
• Familiarity with 21 CFR Parts 820 and 211, ISO 9001, ISO 13485, and GAMP 5
• Experience participating in regulatory audits and inspections
• Knowledge across quality disciplines including validation, calibration, and quality control
• Proficiency in Microsoft Office tools and Electronic Document Management Systems
• Knowledge of statistical methods and continuous improvement methodologies (Lean / Six Sigma)
• 3+ years of experience in the pharmaceutical or medical device industry
• Background in medical device or pharmaceutical manufacturing and sterilization
• Demonstrated understanding and application of ISO…