Plant Quality Manager

Scope of Position

In this role, you will be accountable for product and process compliance to regulatory, customer and Corning Life Sciences standards. We look for you to provide leadership, development and coaching for the plant quality organization. As a member of the plant Leadership Team, the Quality Manager shares accountability for overall plant performance for safety, quality, service and continuous improvement. We look for you to promote 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 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 (Business Ops, Development, GSM, Engineering, Supply Chain, etc.) in order toensure 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, ASTM, GLP, 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. 

Requirements

• Bachelor’s Degree in Life Sciences or Engineering
• Minimum of 10 years of related experience in quality
• 5+ years of manufacturing experience; 3+ years of experience in Pharmaceutical/Medical Device industry preferred
• Prior supervisory/managerial experience  
• Experience in a regulated manufacturing environment
• Must be familiar with 21 CFR parts, 820, ISO9001, 13485 
• Must have participated in related audits/inspections 
• Knowledge base in all aspects of Quality including validation, calibration, quality control 
• Knowledge of processes and practices of other disciplines which interface with Quality
• Knowledgeable in Microsoft Office tools, Electronic Document Management Systems
• Knowledge of key statistical methods and proficiency in Continual Improvement Methods (Lean / Six Sigma) 

Desired Skills

• Medical device or pharmaceutical manufacturing and sterilization background. 
• ASQ Certifications (CQA / CQE / CMQOE) 
• CQE certification 
• Production or engineering management 
• Certified Six Sigma Black Belt 
• Working knowledge and understanding of manufacturing related accounting and other financial systems including budget processes is beneficial