Quality Director, Compliance
•Provides Global Quality Compliance direction to Business Unit(s), local sites, and others as needed to establish and implement practices and procedures that comply with applicable regulations, current industry and regulatory guidelines, and Alcon/Novartis global standards.
- Provides compliance guidance to critical investigations (e.g., non-conformance, OOS, deviation, complaints, etc.) to ensure that issues or events are escalated as required, reporting requirements to regulatory authorities are met, and that investigation, analysis, corrective/preventive actions, and documentation are comprehensive and timely.
- Performs detailed audits of practices at company manufacturing plants and sites to ensure that policies and procedures comply with guidelines set forth by all applicable regulations both domestic, international, and applicable ISO standards.
- Consults with manufacturing management to establish practices and procedures that comply with all applicable regulations.
- Work with manufacturing sites to coordinate inspection management for Novartis and Health Authority audits/inspections.
- Coordinate and review responses to Health Authority observations and queries/reporting regarding market actions.
- Coordinate Compliance Alert analysis with manufacturing sites and prepare Divisional summaries for approval and submission to Novartis. Prepare and present regulatory and Lessons Learned Information via Compliance Forums.
- Coordinate and manage to closure Field Action Assessments and market actions.
- Review escalations for immediate action and follow up. Perform gap assessments for Novartis Quality Directive / Module changes. Review and assess new / revised industry and regulatory standards for Division impact.
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 [email protected] and let us know the nature of your request and your contact information
alrpo EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any 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. Minimum requirements •Bachelor’s degree in Science or Business related field.
- 10 Years in Audit, Compliance, Quality or Manufacturing Operations and 7 years leading people.
- Pharmaceutical or Medical Device Preferred.
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