Associate Director- QA

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 35,000 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.

Purpose:

The purpose of the Associate Director - QA in IAPI (Indianapolis Active Pharmaceutical Ingredient) role is to support the development and implementation of pharmacovigilance system business goals and objectives, enabling the monitoring of the performance of the Pharmacovigilance System. This includes execution of quality system deliverables to ensure compliance, quality oversight of business areas to integrate requirements, audit/inspection support and collaboration within quality and other areas.

Pharmacovigilance System Metrics

• Compiles pharmacovigilance system regulatory compliance metrics/trending to monitor and document regulatory compliance for affiliates, regional centers and central functions, including assisting with the initial investigation of any identified compliance issues and trends.
• Review metrics and trending to improve processes and compliance, as assigned.
• Compile compliance metrics and maintain metrics process.
• Analyze trends, identify areas of weaknesses/gaps and recommend corrective actions.
• Provide updates to quality and business owners.

Pharmacovigilance System Master File (PSMF)

• Collate data required for the update of the EU PSMF and localized PSMFs.
• Management of PSMFs in controlled document management system and ensure assembly of the data in the format required by the regulators.
• Maintenance of required pharmacovigilance quality system summaries and delegations.
• Quality check sections of the EU PSMF to ensure accuracy and consistency.

Audits and Inspections

• To assist in ensuring data is available for audits and inspections.
• Provide support for audits/inspections (e.g., preparation/readiness, coordination, back room, front room, responses).
• Communicate and ensure inspection readiness for areas of responsibilities.
• Have understanding of the role and responsibilities of the European Qualified Person for Pharmacovigilance (QPPV) and ensure support is provided to fulfill the QPPV legal responsibilities.

Other Quality Tasks

• Contribute to the development of area specific procedures and required tools, resource documents and supplemental materials, including review and content approval (as assigned) of quality system documents.
• Participate in quality initiatives and projects as assigned.
• Shares key learning to drive simplification and replicate best practices.
• Collaborates with other quality groups as appropriate and develops quality network.
• Establishes good working relationships with assigned business area(s).

Basic Requirements:

• Bachelor's Degree in a science/technology/health care related field or QBE (qualified by experience)
• 5+ years of pharmaceutical experience

Additional Skills/Preferences:

• IT skills in Office 365
• Effective project and time management skills
• Demonstrated ability to communicate effectively, both written and verbal, and to influence others
• Demonstrated ability to prioritize and handle multiple concurrent tasks
• Cognitive abilities which include problem solving, verbal reasoning, attention to detail, critical thinking and analytical competencies
• Strong interpersonal skills with demonstrated flexibility in varying environments/geographies
• Experience in pharmacovigilance
• IT skills in web-based file sharing platforms and Document Management Systems
• Knowledge of quality system

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As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).

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