Associate Director, Global Quality Compliance

• Lead and implement end to end (design, development, implementation, management) a risk assessment and monitoring program to integrate risk management activities across the Division for global GxP (cGMP/GDP/GLP/GCP/PV) Compliance Risk Management through risk based system assessments, reporting and oversight of remediation activities.
• Lead and implement end to end (design, development, implementation, management) a risk assessment and monitoring program to integrate risk management activities across the Division for global GxP (cGMP/GDP/GLP/GCP/PV) Compliance Risk Management through risk based system assessments, reporting and oversight of remediation activities.
• Must be able to work within multiple time zones to accomplish completion of identified activities.
• Assess and ensure the adequacy of Divisional risk based reporting to ensure appropriate control systems are in place to ensure compliance, mitigation of risks and drive continual improvement.
• Use of data-mining to identify areas for improvement Division wide.
• Based on data analytics manage the compilation, review and dissemination of risk based reporting throughout the Alcon network using compliance communication tools to facilitate robust knowledgement management and to drive identification and remediation of identified risks.
• Based on data analytics, identify negative trends, systemic gaps within the GxP quality systems.
• Collaborate within the Division leads to identify appropriate global CAPAs and remediation plans for Divisional implementation.
• Lead and manage the oversight of the Alcon Compliance Alert /Lessons Learned process and internal knowledge sharing to ensure communication throughout the Division for significant compliance events.
• Identify Divisional compliance initiatives to enhance Divisional compliance profile.
• Globally align risk areas with Senior stakeholders by seeking insights on common trends.
• Ensure consistency of risk management monitoring and reporting methodology.
• Perform monthly, quarterly, annual trend Divisional risk management reporting.
• Thorough knowledge of standard statistical quality concepts, practices, techniques, current industry and regulatory guidelines.

• Successful project outcomes.
• Review and verification for completion of global / site compliance remediation plans and distribution of Divisional risk management reporting.
• Routine review of quality assessment activities to assure problems occurring are corrected and the corrections are monitored for effectiveness and timeliness.
• Identification and mitigation of potential risks identified through data analytics and statistical analysis. 
• Monitoring of internal and external (Health Authority / Notified Body) audit/ inspection observations to ensure the facilities, equipment, personnel, methods, practices, records and controls are in conformance with the regulations and support a successful future compliance outcomes. 
• Through Quality KPIs and project based KPIs, monitor the global compliance program to ensure appropriate planning, performance, reporting occurs so as to generate information by which the hazards and risks to the organization can be assessed. 
• Assessing key stakeholder feedback and alignment on risk management and compliance program improvement opportunities and implementation.
• Meeting key milestones in the implementation of risk management monitoring projects.
• Alignment of risk management and compliance standards across the Division
• Development and tracking of departmental budget, as assigned. 
• Meeting individual performance goals as defined in annual objectives.

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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Posting Title
Associate Director, Global Quality Compliance

Minimum requirements
• Bachelor's degree from an accredited institution in Chemistry, Pharmacy, Microbiology, Biology, Engineering or another related science or equivalent years of directly related experience.
• The ability to fluently read, write, understand and communicate in
• Fluent in English
• 7 years of Relevant Experience

Job Type
Full Time

Country
USA

Work Location
Fort Worth, TX

Functional Area
Quality

Division
ALCON

Business Unit
QUALITY ASSURANCE AL

Employment Type
Regular

Company/Legal Entity
Alcon Laboratories, Inc.

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.


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