Corning is one of the world’s leading innovators in materials science. For more than 160 years, Corning has applied its unparalleled expertise in specialty 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.
The Plant Quality Manager is accountable for product and process compliance to regulatory, customer and Corning Life Sciences standards. The Plant Quality Manager is accountable to provide leadership, development and coaching for the plant quality organization. As a member of the plant Leadership Team, the QM shares accountability for overall plant performance for safety, quality, service and continuous improvement.
The QM promotes the creation of a culture of Quality throughout the plant and ensures compliance with CLS quality systems, policies, procedures and practices and all local, state, federal and Corning safety regulations, policies and procedures
Duties & Responsibilities:
Responsible for developing and maintaining plant strategic quality plan and policies.
Accountable for the effective execution of processes carried out by prioritizing and managing people, resources and budget to accomplish expected requirements and performance.
Engages and provides leadership directions/objectives, coaching and personal development of Associates to perform to their best ability and meet both personal and plant objectives.
Acts as the plant “Management representative” for Notified Bodies and liaison with Regulatory authorities and customers, by hosting related audits and ensuring effective resolution.
Builds an influential and effective network and communication with Plant Leadership Team, CLS Division Quality and Regulatory functions, other plant Quality Managers and other key functions (R&D, Engineering, Supply Chain, etc.) in order to insure alignment around global and local priorities and in driving overall plant performance relying on a strong culture of Quality and Continuous Improvement.
Maintains the Quality Systems to ensure compliance to International standards (ISO) and other industry standards such as USP, etc. as applicable.
Ensures that Management Reviews are conducted in collaboration with the plant manager
Ensures that timely, accurate, qualified and cost effective testing is performed on Raw Materials, Critical Facility Utilities, In-process Materials, Finished Goods and Procured Finished Goods.
Ensures that appropriate Quality Assurance and Quality Control resources are available to assist in the resolution of technical issues affecting supply of Raw Materials, Critical Plant Utilities, In-process Materials, Finished Goods and Procured Finished Goods.
Develops/approves strategic quality planning.
Directs, reviews and evaluates Quality Assurance projects.
Other duties as required.
Bachelor’s Degree in Life Sciences or Engineering. MS Degree helpful.
Minimum of 5 years of related experience in quality
2+ years of manufacturing experience
Must be familiar with 21 CFR parts, 820, 210/211, ISO9001, 13485
Must have participated in related audits/inspections
Strong knowledge base in all aspects of Quality including validation, calibration, quality control
Knowledge of key statistical methods and proficiency in Continual Improvement Methods (Lean / Six Sigma) required.
3+ years of experience in Pharmaceutical and/or Medical Device industry
Prior supervisory/managerial experience
Medical device manufacturing and background, preferably including sterile pharmaceutical processes.
ASQ Certifications (CQA / CQE / CMQOE) preferred
Production or engineering management preferred
Certified Six Sigma Black Belt preferred.
Working knowledge and understanding of manufacturing related accounting and other financial systems including budget processes is beneficial.
Excellent interpersonal skills are required to interact with a broad range of associates at various levels of the organization.
Ability to work cross-functionally with other areas of the organization