Associate Director - Drug Product External Manufacturing - Technical Services

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.

• This role is responsible to lead the technical service primary loop team responsible to provide technical oversight of the technical activities related to the support of external manufacturing as defined in the Global Contract Manufacturing Standards.
• This role is responsible of both technical excellence and compliance while meeting deliverables for day to day operation on making and supply medicines and new product commercialization.
• Has responsibility for ensuring all products are manufactured according to a validated process, following the approved control strategy and maintaining in a validated state during the product cycle.

• Provide oversight to ensure reliable supply of medicines through effective and efficient manufacturing process.
• Ensure capable and in control processes ablish and maintain robust control strategy for all manufacturing/packaging/distribution operation and those meet the Lilly standards/expectations.
• Ensure process definition of critical parameters are in alignment with regulatory submission.
• Ensure that each of the department and external partner operate in compliance with cGMPs, regulatory commitments and Lilly Functional Standards through appropriate oversight. Ensure inspection readiness at all times.
• Ensure Quality of the externally manufactured products through appropriate oversight, CAPAs, metrics and monitoring systems.
• Build relationships with CMs to ensure alignment of intents and objectives.
• Validation: ensure proper definition of strategies, revisions, protocol approvals, validation plans, final reports and master plan. Approve strategy documents and applicable protocols.
• Change Control:
  Properly evaluate and assess impact of proposed changes to validated processes, regulations, relationship and regulatory commitments.
• Deviations:
  Properly evaluate impact on product and processes. Properly evaluate impact on validated process and the control strategy. Ensure proper root cause identification and establishment of effective corrective action plans to prevent reoccurrence.
• Ensure investigations are completed in an appropriately and timely fashion.
• APR, ARs and OPVs:
  Ensure that all process reviews are conducted and all identified or changes are completed 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 in compliance.
• Build relationships externally to Lilly to create benchmark opportunities and identify best practices.
• Oversees the execution of the technical agenda and each external partner, in line with business plan (BP), cGMPs and internal standards.
• Escalate to Sr. 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 need related to process improvement, control strategy or new regulation and ensure any emerging need is incorporate in the CMs technical agenda.

• Contribute to CM selection process by assessing capabilities of external companies and providing functional recommendations to sourcing options (if applicable).

• 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 the BP implementation within the established targets.
• Establish effective networking with internal stakeholders and ensure alignment with central TS/MS and development.
• Partner with Joint Process Team (JPT) Leader,…