Plant Quality Manager, Oneonta

• ◆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 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.

• ✓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 le