Plant Quality Manager, Oneonta

Corning Incorporated; Town of Oneonta (NY); On-site; USD 134,000 - 185,000; Full time

Benefits offered by this job

Bonuses and long-term incentives

Company-paid pension / 401(k) with 7-?

Health and wellness benefits

Paid time off

Job summary

Corning Life Sciences seeks a Plant Quality Manager to lead quality strategy, compliance, and continuous improvement at its Oneonta facility. You will build a culture of quality across the plant and influence safety, service and performance.

You will oversee QA/QC, regulatory audits, and cross-functional collaboration to align quality priorities with engineering, supply chain, finance and regulatory functions in a regulated manufacturing setting.

Qualifications

• 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 EDMS.

Responsibilities

• 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

Skills

Quality management

Regulated manufacturing

Leadership / supervisory

Quality systems

Statistical methods

Lean / Six Sigma

MS Office

EDMS

Education

Bachelor's degree in Life Sciences or Engineering

Tools

Electronic Document Management Systems

Job description

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. Requisition Number: 78688 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. 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

Role Purpose

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.

Key Responsibilities

• 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

Experiences/Education - Required

• 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)

Experiences/Education - Desired

• 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 14971
• ASQ certifications: Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or Certified Manager of Quality and Organizational Excellence (CMQOE)
• Production or engineering management background

This position does not support immigration sponsorship.

The range for this position is $134,306.00 - $184,671.00 assuming full time status. Starting pay for the successful applicant is dependent on a variety of job-related factors, including but not limited to geographic location, market demands, experience, training, and education.

A job that shapes a life.

Corning offers you the total package.

Your well-being is our priority. Our compensation and benefits package supports your health and wellness, financial aspirations, and career from day one.

• Company-wide bonuses and long-term incentives align with key business results and ensure you are rewarded when the company performs well. When Corning wins, we all win.
• As part of our commitment to your financial well-being, we provide a 100% company-paid pension benefit with fixed contributions that grow throughout your career. Combined with matching contributions to your 401(k) savings plan, Corning’s total contributions to your retirement accounts can reach between 7% and 12% of your pay, depending on your age and years of service.
• Our health and well-being benefits include medical, dental, vision, paid parental leave, family building support, fitness, company-paid life insurance, disability, disease management programs, paid time off, and an Employee Assistance Program (EAP) to support you and your family.
• Getting paid for our work is important, but feeling appreciated and recognized for those contributions motivates us much more. That’s why Corning offers a recognition program to celebrate successes and reward colleagues who make exceptional contributions.

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.

Corning is committed to providing equal employment opportunities and considers requests for reasonable accommodations in accordance with applicable laws. Individuals with disabilities or sincerely held religious beliefs may request reasonable accommodations to participate in the application or interview process, perform essential job functions, or access other benefits and privileges of employment. To submit a request for reasonable accommodation related to disability or religion, please contact us at [e-mail].