Assoc Dir, Corp R&D Med Safety Quality
Provide input and assist in establishing the vision and strategic direction for the Medical Safety Quality Assurance (MSQA) department. Ensures 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.
Provides leadership and sound business ethics in the interpretation and implementation of global compliance programs, computer system and/or software validation and related services and compliance training. Advise senior management of the need for corrective and preventive actions with a key advisory role in the development of action 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. Assist in 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, and other associated departments (e.g., Medical Affairs, Regulatory Affairs) 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 (i.e., Medical Affairs, Regulatory Affairs, others as identified). Develops unique approaches to promote and instill a culture of quality and compliance. Drives/facilitates collaboration of quality/compliance improvement initiatives. Lead tracking and communication of the R&D Quality Plan cross-functionally. May 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. Provide coaching, and aid in the development of MSQA staff. 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
Fluent in written and spoken English. Additional languages preferred.
7 years directly related experience
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