Lilly is looking for an Associate Director to provide management oversight for quality system activities in the medical device complaint handling area, supporting the implementation and maintenance of the complaint handling elements of the quality system for devices and drug/device combination products.
Requirements
- Experiences with Complaint processes, IT tools, and reporting
- Technical knowledge in design, manufacturing or validation; preferably devices
- Technical knowledge of complaint handling and quality systems; preferably devices performance
- Regulatory inspection experience
- Knowledge of regulatory requirements (e.g., cGMP, 21 CFR 820, ISO13485, applicable regulations for Canada, US, Australia, Brazil and Japan)
- Experience partnering with external parties/supplier/consultants
- Experience with Six Sigma methodology, e.g., participation on Six Sigma projects
Responsibilities
- Review and approve complaint investigations associated with use, design, and manufacturing investigations for medical devices and drug/device combination products
- Maintain key product and process metrics reporting the performance of the quality system to management with executive responsibility and ensure timely escalations when necessary
- Drive product and process improvements using Root Cause Investigations, Complaint Actions, Trends, and Review Management
- Network within and outside of Lilly device organization to identify and implement opportunities for improvement and/or transfer of complaint handling Best Practices
- Review / write / approve GMP documents including technical reports, deviations/observations, procedures, and work instructions
- Collaborate and provide customer service for groups across Lilly. Share technical and complaint process knowledge and support investigations as needed.
- Support complaint related activities associated with new product launches
Other
- Lead, mentor, coach and provide feedback to employees including participation in organizational planning, HR activities, financial management, and diversity objectives
- Support projects as part of cross functional Lilly teams
- Ensure that adequately provided for the completion of complaint investigations
- Support device development processes by providing complaint analyses of predicate products as design input and by supporting complaint handling activities for clinical trials.
- Assist with and respond to internal and external audits/inspections
