Associate - Quality Assurance - Drug Product 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.

Drug Product External Manufacturing (DPEM) Quality Assurance assures patients worldwide of safe and efficacious drug products, through effective quality oversight of North, Central and South American contract manufacturers and alliance partners. This oversight covers the process steps of selection, pre-validation/validation, ongoing operations and termination. DPEM 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 QA Lead for Contractor Manufacturers (CMs) provides daily oversight, assistance, and guidance to issues such as deviation investigations, change control proposals, procedure/ master formula revisions, validations and other duties associated with daily CM activities. This role provides and assures compliance to Lilly GQS by resolving identified procedural gaps and is responsible for assuring the CM maintains a state of control with regards to manufacturing and/or packaging product.

The QA Lead is integral for maintaining GMP compliance and providing support during preparations for Pre‑Approval/ General inspections by various agencies. The QA Lead is integral for launching new products, packages, processes, and CM's.

The Principal Associate QA may also be responsible for final disposition of manufactured and packaged drug product batches. This role ensures all batches meet specifications, are manufactured/packaged in accordance with validated processes and are compliant with cGMP requirements and regulatory requirements.

Key Objectives/Deliverables:

• Lead/ provide support to launch new products/ packages/ CMs

• Participate on Joint Process Teams

• Understand Lilly global quality systems and monitor the CM process to ensure it is compliant as applicable and ensure complaint to Regulatory expectations.

• Levelling, reviewing, and approving of event investigations and changes.

• Work with Lilly support groups and SME’s to resolve product related issues

• Participate in the creation and revision of standard operating procedures

• Participate on Six Sigma Projects to help improve productivity

• Provide support on site or remotely during inspections

• Author and track compliance to the CM Quality Agreements and CM Quality Plans

• Ensure CMs are following Quality Agreement and appropriate quality systems as part of routine operations. Use regular visits, JPTs and other communications to help to assess/monitor performance.

• Routinely have face‑to‑face communications with CMs

• Track and monitor Quality metrics for trends at the CM

• Support Qualifications/ Validation document creation and reviews

• Provide and coordinate designated sections for Annual Reports and Annual Product Reviews

• Execute SOP assessments of CMs and track completion of outstanding issues

• Support CMs effort to maintain and improve their quality systems

• Provide technical leadership and project management oversight to drive improvements to CM quality systems

• Build and maintain regular communication with External Manufacturers and awareness of issues/progress including reporting back to DPEM Management. Also responds to request of information and data.

• Benchmark with other Lilly sites to share best practices and drive improvements to CM oversight

• Network with external partners and resources to share and learn best practices and trends within the industry

• Support batch release activities by determining final disposition of batches by reviewing all required documentation including but not limited to change controls and deviations.