PRD - Early Phase QA - Advisor/Sr. Advisor

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.

About the Job

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.

Position Brand Description:

Early Phase Quality Assurance is accountable for GMP Quality dedicated to the PR&D Early Phase Team.  This position is responsible for providing technical leadership to the Early Phase Quality Unit and as well as providing day to day Quality oversight to the Early Phase teams and external partners in support of executing the portfolio of both early phase development assets within PR&D, SMDD and BRD.

Key Objectives/Deliverables:

• Support delivery of early phase Pre-Commercialization Information and Materials within the Early Phase portfolio (typically through Phase II); ensuring quality expectations/requirements are consistently met.
  • Ensure appropriate execution of the Early Phase Quality System to sustain compliance with regulatory requirements and good manufacturing practices
  • Review and approve manufacturing documentation
  • Disposition API, in-process materials, dosage forms and finished drug product to be used in Clinical Trials including management and review of GMP documentation, analytical results and regulatory commitments.
  • Coordinate deviation and complaint investigations, as needed
  • Review and approve deviations, change documents, and specifications for Early Phase materials
• Provide QA input to CM&C Development Plans as part of Early Phase deliverables.
• Ensure contract manufacturers and packagers, testing laboratories, vendors, and suppliers are qualified to assure compliance and integrity of the supply chain and oversee partner activities within a manner that optimizes compliance as well as efficiency.
• Collaborate with internal business and quality partners (SMDD, BR&D, PD, ELECTS) to ensure appropriate Lilly oversight of Early Phase activities at external partners
• Maintain and execute a Quality System aligned with LQS, GQS, and PR&D QS commensurate with Early Phase scope and phase of development.
• Provide on-site support at partners/CMO’s for manufacturing, packaging and labeling activities of investigational medicinal products, and materials used to produce IMPs as necessary.
• Provide on-site support for internal manufacturing, packaging, labeling and distribution activities of investigational medicinal products, and materials used to produce IMPs as necessary.
• Identify opportunities for, and participate in, continuous improvement
• Ensure inspection readiness through site self-assessments, GMP education, monitoring, establishing and enhancing Quality systems and provide support for internal and regulatory site inspections
• Influence PR&D QA management via identification and/or implementation of process improvement opportunities for external party governance within PR&D Early Phase.
• Actively monitor changes to global compliance environment, and industry developments, assess impact/compliance of Early Phase Quality system and quality strategy, and implement necessary changes.
• Mentor, coach and develop Early Phase QA Team Members.

Minimum Requirements:

• Demonstrated relevant experience in global clinical trial cGMP regulations
• Breadth of technical and quality knowledge including API, drug product manufacturing, clinical trial packaging, analytical laboratories.
• Demonstrated expertise of cGMP and Quality Systems with a minimum of 5 years internal Lilly and external experience in any of QA, QC, Manufacturing MS&T, or Regulatory
• Ability to interpret/apply phase-appropriate GMP standards
• Proficiency with applicable computer systems.
• Demonstrated strong oral and written communi