Sr Manager, Audit job in Fort Worth
|Employer:|| Novartis Pharmaceuticals|
|Job Type:||Full Time|
•The Sr. Manager, Audit will participate, lead as appropriate and direct the scheduling, management and execution of Alcon and non-Alcon entities' GxP audits worldwide. |
•Position requires up to 50% domestic and international travel for a duration up to 3 weeks.
•Conduct worldwide corporate audits according to audit programs for medical device manufacturers, pharmaceutical manufacturers, contract manufacturers, contract laboratories, suppliers, service providers, vigilance operations (pharmaceutical and medical devices), distribution centers, and affiliates
•Provide objective audit reports and assessment for audit targets based on regulatory and Alcon corporate requirements
•Provides written audit reports and observations in a timely manner and assure correctives are adequate and timely
•Work collaboratively with auditees to ensure proper and effective CAPA's
•Provide global GxP consultation, guidance and assistance using the principles of risk evaluation and mitigation
•Reviews regulatory requirements, standards, and inspection trends for incorporation into Alcon procedures and audit practices
•Maintain adherence to the corporate audit schedule/plan and department budget
•Performs other duties as assigned and adhere to all applicable company procedures & policies, cGMPs, and any other applicable external quality and regulatory requirements (e.g. FDA, EMEA, ANVISA, TGA, Health Canada, etc.).
Alcon is an Equal Opportunity Employer and participates in E-Verify. As part of the Novartis Group of Companies, 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, 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 e-mail to firstname.lastname@example.org and let us know the nature of your request and your contact information.
•The ability to fluently read, write, understand and communicate in English
•7 Years of Relevant Experience
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