Sr. Director, Quality Assurance Compliance

At Alcon were passionate about enhancing sight and helping people see brilliantly. With more than 25000 associates we innovate fearlessly champion progress and act swiftly to impact global eye health. We foster an inclusive culture recognizing your contributions and offering opportunities to grow your career like never before. Together we make a difference in the lives of our patients and customers. Are you ready to join us

This role is part of Alcons Quality & Regulatory Affairs function a team that ensures our products are in compliance with global local and internal regulations and meet the strictest standards of quality as we help people see brilliantly.

The Sr. Director Quality Assurance Compliance (Management Path) is primarily responsible for developing implementing managing and monitoring Alcons global strategies for Corporate Quality Compliance programs and initiatives for success and sustainability both internally as well as externally with Health Authorities.

Specifics include :

• Accountable in ensuring enterprise compliance to EU MDR 2017 / 745.
• Coach and develop both direct and as appropriate indirect reports through ongoing example-based performance feedback and the provision of training and development opportunities.
• Strategically contributes to the development articulation implementation and continuous improvement of Global Quality projects policies and compliance programs.
• Communicate critical assessments to Senior Leadership regarding the state of compliance and quality so as to provide insights into risks or potential concerns (business patient safety etc.) and drive actions across the business to implement plans to improve compliance and quality performance.
• Supports in directing administration and management of the Corporate Quality support for Health Authority inspections by providing onsite manufacturing strategic pre-inspection preparatory support and provide strategic direction during Health Authority inspections.
• Contributes to negotiation of Alcon corrective action plans with Health Authorities (FDA EMA Competent Authorities etc.) associated with inspectional observations so as to drive favorable Health Authority results.
• Supports in directing administration and management of the Global Incident Management process (Escalation Field Action Assessments HA Reporting to include US Field Alert Reporting Market Action Compliance Alert Compliance / Auditing Forums).
• Responsible for implementing the Global Market Action / Recall Management including cross functional risk assessment and input for global impact of internal and external notifications product availability / replenishment etc.
• Strategically contributes to external Health Authority submission management (FDA EMA Competent Authorities etc.) for global statutory reporting analysis of corrective actions risk assessment destruction and statutory termination activities of market action activities.
• Responsible for the creation implementation and maintenance of all Alcon Computer Systems Validation standards and processes resulting in GxP-compliant high quality IT solutions fit for their intended use.
• Drives strategic planning and operational execution for Data Integrity (DI) initiatives including setting the direction defining priorities giving operational guidance to ensure alignment of DI concepts according to standards and Health Authority regulations.
• All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs) maintaining accurate and complete documentation ensuring rigorous quality control and completing all required training. Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization. Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations.

What youll bring to Alcon :

Preferred Qualifications / Skills / Experience

How you can thrive at Alcon :

Alcon Careers

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ALCON IS AN EQUAL OPPORTUNITY EMPLOYER AND PARTICIPATES IN E-VERIFY

Alcon takes pride in maintaining an inclusive environment that values different perspectives and our policies are non-discriminatory 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 email to and let us know the nature of your request and your contact information.

Required Experience :

Exec

Key Skills

Quality Assurance,FDA Regulations,ISO 9001,Root cause Analysis,Biotechnology,Clinical Trials,Quality Systems,Food Processing,Quality Control,Quality Management,cGMP,HACCP

Employment Type : Full-Time

Experience : years

Vacancy : 1