Global Quality Systems Auditor

A global eye care leader, CIBA VISION has one of the most exciting product pipelines in the industry today. A pipeline of innovative contact lenses and lens care products brought to life by diverse, talented, performance driven people who share a passion for healthy vision and better life. All of which makes us one of the most rewarding employers in our field.How do you spend your day? Are you passionate about what you do? At CIBA VISION, our focus is clear, our purpose defined. We are part of a team that is making a difference in the quality of peoples lives.Think what's possible. The purpose of this position is to facilitate and/or implement the following:- Determine the level of compliance to FDA Quality Systems Regulations, applicable ISO Standards and Novartis quality requirements. - Ensure that sufficient regulatory compliance is being maintained in all CIBA Vision manufacturing, sales/marketing and Research/Development organizations.- Develop and maintain metrics that provide an overall status of compliance throughout CIBA VISION.PRIMARY RESPONSIBILITIESMaintain Internal Auditing Program- Maintain an Auditing Program that is in compliance with cGMP, ISO-13485, Novartis and CIBA Vision's quality requirements- Support and Facilitate a practical and comprehensive auditing schedule- Manage Audit Reports/CAPA's to closure- Ensure that auditing deliverables are properly addressed and closed in a timely manner- Ensure that clients thoroughly understand all audit observations and response requirementsCoordinate External Auditing Program- Coordinate strategy and provide support in external inspections of CIBA Vision's facilities- Support and Facilitate responses to external audit observations- Ensure that Audit Responses/CAPA's are closed in an acceptable time period Requirements Harmonization- Maintain/Facilitate the process for evaluating new compliance requirements from Novartis and External Health Authorities- Maintain/Facilitate the process for managing the implementation/ execution of new compliance requirements- Maintain/Facilitate the process for the resolution of unclear/ambiguous requirements from Novartis and External Health AuthoritiesQualificationsMinimum Education Required:- Associates Degree/Level of collegiate education Preffered Level:- Bachelors degree in a scientific/related disciplineMinimum Experience Required:- At least 7 years of experience working as a quality professional in a GMP/GCP/GLP regulated environment- At least 3 years chairing the development, administration, management and maintenance of a multi-site CAPA Program- 3 - 6 years experience in external quality auditing in a GMP regulated environment. Familiar with ISO and FDA requirements. Preffered Level:- At least 10 years of experience working as a quality professional in a GMP/GCP/GLP regulated environment- At least 7 years chairing the development, administration, management and maintenance of a multi-site CAPA Program- 7+ years practical experience in Quality auditing and 3rd party management in a large multinational medical device or pharma companyMinimum Skills Required:- Certified Quality Auditor (CQA)- Advanced knowledge and application of Microsoft applications- Excellent communications skills (verbal and written)- Ability to develop concise presentations for Senior Management- Ability to take multiple data sources and develop a concise visual summary- Ability to evaluate and determine the legitimacy of recommendations/actions from multiple departments Preferred Level:- Proven negotiating skills- Certified Quality Engineer (CQE)- Certified Quality Manager (CQM)- ISO lead auditor
Novartis is committed to embracing and leveraging diverse backgrounds. Novartis is an equal opportunity employer M/F/D/V.To apply for this position, Click HereTo learn about other Novartis opportunities, Click Here