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Plant Quality Manager

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Date: Jul 26, 2022

Location: Bedford, MA, US, 01730-1414

Company: Corning

Requisition Number: 53333

 

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:

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 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, 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.

 

Travel Requirements:

  • Negligible

 

Hours of work/work schedule/flex-time:

  • Standard business hours; Monday – Friday.

 

Required Education:

  • Bachelor’s Degree in Life Sciences or Engineering.

 

Required Years and Area of Experience:

  • 6 years of related quality experience.
  • 5+ years of manufacturing experience
  • Prior supervisory/managerial experience 

 

Required Skills:

  • Must have regulated 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 processes and practices of other disciplines which interface with Quality.
  • Knowledgeable in Microsoft Office tools, Electronic Document Management Systems and SAP

 

Desired Experience / Qualifications / Skills:

  • Experience in medical device or pharmaceutical manufacturing and sterilization background
  • 3+ years of experience in Pharmaceutical / Medical Device industry
  • Knowledge of key statistical methods and proficiency in Continual Improvement Methods (Lean / Six Sigma)Lean Six Sigma experienceASQ Certifications (CQA / CQE / CMQOE)
  • CQE certification
  • Production or engineering management 
  • Working knowledge and understanding of manufacturing related accounting and other financial systems including budget processes is beneficial

 

Soft Skills:

  • Excellent interpersonal skills are required to interact with a broad range of associates at various levels of the organization.

 

 

 

This position does not support immigration sponsorship.

 

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, disability status or any other legally protected status