Lead Glbl Cust-Oriented Device-Prog Comp
The purpose of the role is to ensure the process for Alcon Customer Oriented Device Program (CODP) activities, initiated and conducted by global business franchises, regions and countries across Alcon are in compliance with Adverse Event and Technical Product Complaints company policies and federal regulations. The position provides guidance to all global and regional marketing teams for initiating and executing CODPs according to global standards and requirements. Foster and champion a quality culture and mindset to develop a collaborative relationship with CODP stakeholders (e.g., Alcon Commercial business functions, Patient Safety, Complaint Handling, etc.) to maintain a sustainable compliant global CODP system that is consistently applied in all circumstances.
- Acts independently as an authoritative agent of the Global CODP Office with responsibility for approvals as well as vendor disqualification and/or program discontinuations for noncompliance.
- Acts as an integral part of the quality team through review and approval or rejection of documentation for program closure within a validated database and in acting as a key con-tact/subject matter expert for all global vigilance audits or inspections related to customer facing programs and requirements.
- Function as a global conduit for worldwide issues escalated for CODP Governance Committee review and conversely assure proper execution of programs through established metrics, performance of company level self-inspections, and ongoing interactions with country safety, quality and complaint handling teams
- The CODP Lead is responsible for maintaining up-to-date knowledge of global standards and requirements and for communicating key company positions or policies to stakeholders; additionally responsible for development and/or revision of key training tools and/or approved messaging to facilitate adherence to requirements
- Function as primary contact for business owners or proxies with regard to the program data-base, development of user training, requirements and curricula, tracking of user training and general maintenance of the global database.
- Develop and maintain strong partnerships with cross-functional colleagues to assure alignment of processes and procedures as well as mitigation of risks associated with non-compliance
- Provide monthly reports to management on CODP activities, issues and escalations and participate in internal/external CODP investigations including entering deviations and assisting stakeholders with CAPA plan development, execution and closure requirements.
- Collaborate with regional and global CODP stakeholders to ensure consistency and alignment of CODP training, procedures and reporting requirements
- Influence decision making across franchises, regions and countries and between commercial, quality and safety functions and escalate issues to management as appropriate
- Assure that CODP processes are adequately proceduralized and aligned with current corporate quality, safety and regulatory compliance guidelines.
- Provide ongoing monitoring of individual CODP programs through the CODP system/database to prevent and mitigate risks associated with non-compliance
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 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, Business, or equivalent
Excellent English language skills – verbal and written
At least 5-7 years of experience in Quality Assurance, Medical Safety, R&D or customer interfacing positions in the medical device industry (or equivalent) Investigator/audit/CAPA training a plus
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