At Lilly, we unite caring with discovery to make life better for people around the world.
We are a global healthcare leader headquartered in Indianapolis, Indiana.
Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.
We give our best effort to our work, and we put people first.
We're looking for people who are determined to make life better for people around the world.
The purpose of the role is to support the development and implementation of quality systems strategy and activities to support International Business Unit (IBU) goals and objectives for assigned countries or regions.
Serve as primary Quality point of contact for assigned area (Clinical development, Safety/Pharmacovigilance and/or Regulatory) for Spain and Portugal.
In support of this mission, the purpose of this role within an Affiliate/Region is to act as a quality consultant and leader in integrating the quality requirements into the business processes.
The role will implement the quality plan and ensure consistency between the global requirements and local requirements.
This includes the implementation of Safety and Efficacy quality system and assuring that this system is aligned with appropriate quality and regulatory requirements.
Provide updates on internal/external GxP trends and changes through the country/regional affiliate leadership team(s).
Acting as a contact person regarding quality and business process compliance concerns between affiliates and global.
Responsibilities Implement and Manage Quality Systems Contribute to the development and review of country/region specific quality system documents to ensure requirements and accountabilities are represented.
Approve regional and/or local required tools, resources, forms, templates.
Assist in interpreting relevant regulations and guidelines and act as a contact person for global and affiliates.
Recommend new procedures or changes to existing procedures where applicable.
Responsible for deviations, change controls, Notification to Management (NTM), ensuring events are appropriately documented, escalated, and completed.
Conduct root cause analysis and implement Corrective Action and Preventative Action (CAPA) process.
Support the business on the application and facilitation of quality systems (deviations, notification to management, change control).
Support activities and processes related to external party management (such as, third-party organizations, business alliance partners) as assigned.
Perform quality self-assessments, as needed.
Provide Quality Oversight for business area(s) Monitors and provide quality oversight for compliance to Safety & Efficacy Quality System (SEQS).
Communicates and escalates compliance issues to management locally and globally, as appropriate.
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