Plant Quality Manager

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 PQM shares accountability for overall plant performance for safety, quality, service and continuous improvement. The PQM 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 influential and effective network and communication with Plant Leadership, CLS Division Quality and Regulatory functions, other PQMs and other key functions (Plant Managers, Contract Manufacturing, Product Managers, 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)
  • 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 resources are available to assist in the resolution of issues
  • Other duties as required.

 

Education:

  • Bachelor’s Degree in Life Sciences or Engineering. MS Degree preferred.

 

Experience:

Required

  • Minimum of 8 years of related experience in quality
  • Prior supervisory/managerial experience required
  • Must be familiar with 21 CFR820 and ISO9001
  • Must have participated in related audits/inspections
  • Strong knowledge base in all aspects of Quality Systems and Quality Assurance

 

Preferred

  • 3+ years of experience in Pharmaceutical / Medical Device industry
  • ASQ Certifications (CQA / CQE / CMQOE) preferred
  • 5+ years of distribution experience
  • Working knowledge and understanding of manufacturing related accounting and other financial systems including budget processes is beneficial.

 

Other Qualifications:

  • 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

We prohibit discrimination on the basis of  race, color, gender, age, religion, national origin, sexual orientation, gender identity or expression, disability, or veteran status or any other legally protected status.

Company
Corning
Posted
03/25/2018
Type
Full time
Location
Pittston, Pennsylvania 18640, US