Associate Director - Quality Assurance DPEM

Eli Lilly

Sesto Fiorentino, Italy

Drug Product External Manufacturing Quality Assurance assures patients worldwide of safe and efficacious drug products, through effective quality oversight contract manufacturers and alliance partners. This oversight covers the process steps of selection, pre-validation/validation, ongoing operations, and termination.

Drug Product External Manufacturing Quality Assurance is committed to creating partnerships that facilitate open communication and maintaining effective relationships with our alliance partners, contract manufacturers, and internal business customers.

The Associate Director - Quality Assurance DPEM is responsible of the development, management, and continuous improvement of the DPEM quality system through the Quality Assurance team (QA team). Specifically, the Associate Director - Quality Assurance DPEM will be responsible for quality activities related to start up and maintenance of products and facilities in identified countries.

Key Objectives/Deliverables

General:

Lead the Quality Assurance team including regular contact with remotely located QA team members;
Support QA Representatives to follow appropriate quality systems for complaints, deviations & change controls;
Ensure use of Performance Management system for employees in Quality Assurance team, including developing skills and performance of direct reports;
Perform notification to management of quality issues as necessary;
Respond to requests for data and information from DPEM and CMs;
Delegate for Leader of Quality Assurance;
Contribute to Business Plan and Long-Range Plan;
Approval of technical reports, complaints, change controls, deviation, quality agreements and annual product reports.

Contract manufacturers management:

Support the implementation Quality systems and Q initiatives at CM Level;
Support Corporate audits, CM´s inspections (as required) and follow up on audit findings, ensuring that DPEM are taking appropriate action in due time.

Quality Systems:

Support implementation of Global Quality Standards, Lilly Quality Standards, Global Contract Manufacturing Standards, and local SOPs for DPEM.

Basic Qualifications

Education: Bachelor´s degree in Biology, Chemistry, Pharmacy, or similar technical background;
Experience: Significant experience in technical and quality functions within a manufacturing site and experience managing teams.