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Head, Medical Safety QA

Job Description
•Accountable for establishing the vision and setting the strategic direction for the Medical Safety Quality Assurance (MSQA) department and within Alcon worldwide.
•Ensures that MSQA operates with independence from business partners in order to provide an independent assessment of quality and compliance in global Medical Safety and Pharmacovigilance programs.
•Accountable for organizational effectiveness for the global MSQA organization through management of Novartis operating principles, values, and behaviors.
•Provides leadership and sound business ethics in the interpretation and implementation of global compliance programs, computer systems and/or software validation and related services and compliance training.
•Advise senior management of the need for corrective and preventive actions with a key role as advisors in the development of actions plans and monitoring of effectiveness of action plans as a result of internal MSQA/Pharmacovigilance (PV) audits and those submitted to Health Authorities as a result of inspections.
•Ensures senior management awareness of compliance issues impacting regulatory acceptability.
•Worldwide compliance surveillance, including the assurance of audit and compliance oversight of medical safety organizations; collection and reporting of compliance data according to worldwide legal and regulatory requirements and Novartis standards.
•Develops appropriate measures to assure communication, management and remediation of compliance issues involving Alcon medical safety departments to include analysis of risks and trends.
•Drives MSQA organization excellence via the management of and adherence to quality systems in order to serve all levels of customers and stakeholders.
•Provides guidance and support in the field of medical safety and PV compliance to applicable departments.
•Develops unique approaches to promote and instill a culture of quality and compliance.
•Drives/facilitates collaboration of quality/compliance improvement initiatives.
•Lead the creation, tracking and communication of the R&D Quality Plan cross-functionally.
•Serve as the main point of contact for inspection preparation, conduct, and remediation activities for both national and local inspections (e.g., FDA, MEA, MHRA, etc.).
•Review and approve documentation including but not limited to: Reviewing, commenting and/or approving documents associated with regulatory submissions, notes to file, templates, template revisions, and Standard Operating Procedures (SOPs)
•Author and/or review standard operating procedures and policies as needed.
•Manage direct reports by providing coaching, development and performance appraisals, 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 alcon.recruitment@alcon.com and let us know the nature of your request and your contact information







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