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Quality Site Head - Huntington, United States - Alcon MX
Description
Responsible for all quality and compliance related activities and decisions for the applicable Surgical Manufacturing Facility, and for implementing the Site quality management programs.
Appointed Site Management Representative, per the appointment letter. Participates in the design, implementation, monitoring and maintenance of an effective Quality Management System.
Demonstrate strong and visible support for the Quality Management System, ensure its implementation throughout their organization and advocate continuous improvement.
Ensure products comply with market authorization and GMP requirements and advocate continuous improvement during manufacturing, distribution and shelf life, both for products manufactured at the site and for Third Party products managed by the Site or Functional UnitEnsure management training on and awareness of quality and compliance requirements and systems.
Ensure appropriate disciplinary actions are taken in case of willful or negligent GxP and Quality Management System violations up to and including termination of employment.
Assess the conclusions of periodic review of process performance, product quality and of the Quality Management System.Monitor effectiveness of Quality Management Systems, including performance of self inspections, metrics monitoring and participation in management reviews.
Release and rejection authority for products manufactured at the site as well as materials/components used.
Ensure appropriate and timely escalation to management for quality related matters.
Ensure all personnel are properly trained and qualified to execute their duties
Ensure appropriate interface with authorities for any GxP and Quality Management System related activity.
Conduct periodic management reviews with the Site Leadership Team for process performance, product quality, and the Quality Management System.
Participate in the development of Annual Objectives, and ensure implementation, maintenance, and review at the site level.
Plan and Manage department budget and establish headcount requirements based upon production plans and regulatory requirements.
Member of Business Continuity and Alcon Crisis Management (ACM) team as expert for Product Quality role and backup for ACM Director and Coordinator.
Responsible for providing a work environment free from recognized hazards and ensure compliance with all applicable laws and regulations.Develop the quality organization in terms of knowledge, skill sets and leadership.
Prepare development plans for the direct reports to ensure the Quality organization's effectiveness & succession planning through the Talent Management Review processes.
Coach / mentor Quality and Site staff including awareness for legal and customers' requirements.Bachelor's degree,
Science or Engineering or related Field
7 years In medical
device/pharmaceutical
industry
Minimum 8 years In a Leadership Position
Preferred Experience:
Advanced degree,
Science, Engineering or related field
If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.
Alcon is an Equal Opportunity Employer and participates in E-Verify.Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status.
Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email toand let us know the nature of your request and your contact information.
About Us
At Alcon, we are committed to helping people see better.
We believe patients should have access to quality eye care regardless of their economic circumstances; however, barriers to good eye health exist for patients in both developed and emerging markets.
Alcon develops and manufactures innovative devices to serve the full life cycle of eye care needs. Its surgical group is one of the largest makers of equipment used for cataract removal and laser vision correction. Its consumer products include the well-known Opti-Free line of contact lens solutions and related products. Alcon, which was founded in 1945, sells its products in 180 countries worldwide.If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.
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