Associate Director - Drug Product External Manufacturing - Technical Services

Location: Sesto Fiorentino

Associate Director - Drug Product External Manufacturing - Technical Services Join to apply for the Associate Director - Drug Product External Manufacturing - Technical Services role at Eli Lilly and Company 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.

Responsibilities This role is responsible to lead the technical service primary loop team, providing technical oversight of the activities related to the support of external manufacturing as defined in the Global Contract Manufacturing Standards. It ensures both technical excellence and compliance while meeting day‑to‑day deliverables for making and supplying medicines, and for new product commercialization.

Make & Supply Medicine Provide oversight to ensure reliable supply of medicines through effective and efficient manufacturing processes.

Ensure capable and in‑control processes at CMs; establish and maintain robust control strategy for all manufacturing/packaging/distribution operations that meet Lilly standards.

Align process definition of critical parameters with regulatory submission.

Ensure each department and external partner operates in compliance with cGMPs, regulatory commitments, and Lilly Functional Standards; ensure inspection readiness at all times.

Ensure quality of externally manufactured products through appropriate oversight, CAPAs, metrics, and monitoring systems.

Build relationships with CMs to ensure alignment of intents and objectives.

Validation:
Define strategies, revisions, protocol approvals, validation plans, final reports, and master plans. Approve strategy documents and applicable protocols.

Change Control:
Evaluate and assess impact of proposed changes to validated processes, regulations, relationships, and regulatory commitments.

Deviations:
Evaluate impact on product and processes. Identify root cause and establish corrective action plans to prevent recurrence.

Ensure investigations are completed appropriately and in a timely fashion.

APR, ARs and OPVs:
Conduct all process reviews and complete identified changes in a timely manner and in compliance with applicable standards.

Ensure external manufacturing documentation (e.g., Quality Agreements, Manufacturing Requirements Document, validation documents) is in place and compliant.

Build external relationships to create benchmark opportunities and identify best practices.

Oversee execution of the technical agenda with each external partner, in line with business plan, cGMPs and internal standards.

Escalate to Senior Management in a timely fashion risks to supply, manufacturing issues, major deviations or safety and cybersecurity issues.

Lead implementation and execution of activities aligned with emerging needs related to process improvement, control strategy or new regulation; ensure any emerging need is incorporated in the CMs technical agenda.

New CMsContribute to CM selection process by assessing capabilities of external companies and providing functional recommendations to sourcing options.

Governance Be a member of the Flow Team and Science Lead Team (LT), Site Quality LT.Support the functional Business Plan and participate in the DPEM BP consolidation; ensure BP implementation within established targets.

Establish effective networking with internal stakeholders and ensure alignment with central TS/MS and development.

Partner with Joint Process Team (JPT) Leader, Quality Managers and Secondary Loop to ensure TS/MS members of the JPT complete actions/objectives.

People Provide adequate staffing to meet the technical agenda and the functional agenda.

Lead the performance management process by overseeing development of employee PM plans; conduct interim and final reviews.

Coach,…