Req #: 11124
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.
Scope of Position:
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
Day to Day 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 customer, by hosting related audits and ensuring effective resolution.
- Maintains the Quality Systems to ensure compliance to International standards (ISO) and other industry standards such as USP, ASTM, 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.
Required Education: Bachelor degree in Life Sciences or Engineering
Required Years and Area of Experience: 10 years related experience including at least 3 years of managerial or supervisory experience and 5 yearsof manufacturing experience. (Preferred 3+ years in Pharmaceutical/Medical Device Industry)
- Knowledge of key statistical methods and proficiency in Continual Improvement methods (Lean/Six Sigma)
- Medical device or pharmaceutical manufacturing and sterilization knowledge
- Familiarity with 21 CFR parts, 820, 210/211. ISO9001, 13485
- Audit/inspection experience
- Lean Six Sigma experience
- Strong knowledge base in all aspects of Quality including validation, calibration, and quality control
- ASQ Certifications (CQA / CQE / CMQOE) preferred
- Production or engineering management
- Certified Six Sigma Black Belt
- Working knowledge and understanding of manufacturing related accounting and other financial systems including budget process
- Excellent interpersonal skills
- Knowledgeable in Microsoft Office tools, electronic document management systems (Peoplesoft, ETQ)
- Ability to work cross-functionally with other areas of the organization