Sr. Director – Quality – Molecule API External Manufacturing

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.

API External Manufacturing (API EM) supports the delivery of Lilly medicines by providing oversight of the manufacturing of Small Molecules, Large Molecule and Peptide APIs at external manufacturing facilities globally.

The Sr. Director – Quality – Small Molecule API EM is the Site Quality Leader for the Small Molecule Plant within the API EM organization and is responsible for all quality activities related to the oversight of Small Molecule APIs for commercial products. They ensure that products are manufactured, tested and released in accordance with marketing authorization requirements and cGMPs and drive continuous improvement to adapt to the business requirements.

This role stays abreast of changing internal and external regulatory expectations to focus on continuous improvement and evolving priorities.

• Site Quality Leader for Small Molecule Plant: ensure products are manufactured and released in compliance with marketing authorizations and GMPs.
• Lead the definition of the quality strategy and quality plans for the Small Molecule Plant and align with Site Quality leaders from Large Molecule and Peptide Plants and the broader External Manufacturing organization.
• Ensure the Small Molecule Plant operates in accordance with the quality management system for API External Manufacturing.
• Ensure staff are qualified and that required training of all quality personnel is completed and adapted as needed.
• Develop and maintain robust control strategies for the API EM Small Molecule portfolio.
• Maintain robust batch release execution processes and evaluate batch production records.
• Provide appropriate oversight of Contract Manufacturers and Contract Laboratories and ensure they have effective quality systems in place.
• Support Inspection activities at Contract Manufacturers and Contract Laboratories as required.
• Ensure all required testing is conducted compliantly, including setting specifications, robust sampling processes and investigating anomalies.
• Ensure the site quality system is effective, including execution of the site self-inspection program.
• Investigate and resolve deviations, OOS and complaints.
• Ensure available stability data to support storage, retest or expiration dating periods.
• Participate in and approve annual product reviews.
• Notify senior management of significant quality-related issues.
• Ensure prompt closure of all regulatory commitments.

As a member of the Small Molecule Plant Lead Team, the Sr. Director – Quality – Small Molecule External Manufacturing API shares responsibilities with the Operations Leader as follows:

• Ensure and monitor compliance with local regulations and GMP requirements.
• Authorize written procedures and other key GMP documents.
• Participate in management reviews of process performance, product and data quality, and the quality management system, advocating continual improvement.
• Ensure timely and effective communication and escalation of quality issues to appropriate management levels.
• Ensure the adequacy and effectiveness of the personnel qualification and training program.
• Approve and monitor suppliers of material (where owned by Lilly).
• Approve and monitor contract manufacturers, GMP service providers, and consultants.
• Ensure robust record retention processes for the Small Molecule Plant.

• Serve as the Site Quality Leader for the Small Molecule EM Plant as a member of the Small Molecule API EM Plant Lead Team.
• Ensure site compliance to all cGMPs, procedures, standards, guidelines and regulatory commitments.
• Support quality-related…