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Director of Quality: Company Confidential

Company NameCompany Confidential
Job CategoryPharmaceutical/Biotech; Healthcare
LocationSchaumburg, IL
Position TypeFull-Time, Employee
Salary$125,000 to $155,000 per year + 15-20% Bonus
Experience5-10 Years Experience
Desired Education LevelBachelor of Science
Date PostedJune 10, 2009 (Reposted Nov 19)
View Company Confidential profile and job listings

Director of Quality



Director of Quality:

Manages the quality control function of the company. Ensures the quality of materials purchased, processed, manufactured, and/or distributed by the company. Responsible for continuously reviewing quality control philosophy, practice, and procedure to ensure the highest standards. Establishes and ensures maintenance of training programs for quality control personnel.

Responsible for effective implementation and maintenance of Quality Systems and compliance programs in accordance with various regulations and standards.

Directs multiple Quality Systems functions including CAPA, Complaints, Environmental Programs, Sterilization, local Management Review, change and design review, and all aspects of Manufacturing support for processes and products, including but not limited to incoming and in-process inspection, and finished goods for multiple facilities and/or product families..

  • Working through managers, ensures the effective implementation and maintenance for Quality System requirements, including but not limited to, 93/42/EEC, ISO13485, and 21CFR 820. Ensures organizational compliance with Quality Systems procedures and regulations.
  • Partners with Divisions, Geographies or Functions to pro-actively identify and resolve quality issues and ensures products are manufactured in compliance with written specifications, and meets customer expectations. Regularly monitors the status of corrective actions/preventive actions to ensure quality issues are resolved and products are manufactured in compliance with written specifications.
  • Educate internal constituents on Quality Systems regulations and the impact of the regulations on their roles and responsibilities to foster ownership of QS principles and ensure compliance with QS procedures and regulations.
  • Translates Quality System strategy into tactical plans and ensures implementation.
  • Partners with management in the development and introduction of new products and processes into manufacturing through quality planning including verification and validation...
  • Participates in 2nd party agreements (e.g. contract mfg, distribution, acquisitions etc.) through due diligence activities of quality system assessment, contractual agreement, and quality system integration.
  • Oversees the quality system compliance through internal audit program, local management review, quality meetings, and routine trend analysis of key performance indicators of the facilities and/or product families. Directs corrective and preventive actions as required.

Education and Experience Required:

  • Bachelors Degree. – engineering, life sciences, business required
  • 7+ years related quality assurance experience, including 5 years managerial experience.
  • Demonstrated knowledge and understanding of regulatory requirements of job description.
  • Strong interpersonal skills required to interact with and influence senior level management across the organization.
  • Strong interpersonal skills required to interact with external agencies and regulatory bodies to explain Company policies, procedures and processes.
  • Working knowledge of problem solving techniques and statistics (e.g. six sigma)



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