Deviation Mentor

Overview

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.

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.

Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. We are looking for experienced quality assurance associates to support growth in Lilly Kenosha County (LKC). This is an outstanding opportunity to participate in new manufacturing investments and pioneering technologies.

The Deviation Mentor is a member of the LKC Quality organization who educates, mentors and guides deviation investigations and analytical investigations. The Deviation Mentor also leads the training program for the deviation system and may lead deviation review boards, participate in deviation assessment review pre-approval and post-approval. The Deviation Mentor leads site metrics related to the deviation system. The role may lead complex investigations and collaborates in regulatory inspections, contributing to site inspection readiness and advising lead investigators, functional leaders and Site Quality Leader and Quality Directors in issue investigations.

• Provide advice and guidance to lead investigators in deviation investigations and analytical investigations, including assessment, quality impact evaluation, root cause analysis methods, investigation write-ups, data support, CAPA establishment and effectiveness.
• Coach the deviation review board: review deviations prior to approval. Provide advice and assist deviation reviewers and approvers on issue investigation matters.
• Own elaboration and reviews of deviation trend reports.
• Facilitate the implementation of DRB Playbook at the plants and site level, connect plant/site metrics, trending and procedures with implementation.
• Establish linkages with network and global teams and participate in relevant forums (e.g., global deviation CoP) to ensure communication and implementation of best practices within the site.
• Lead the review of the quality of deviation investigations (post-approval).
• Design and elaborate site deviation metrics; participate in the review of plant deviation trend analysis.
• Integrate global initiatives and projects related to deviation management into site quality standards and processes.
• Design and deliver deviation management training programs.
• Escalate concerns/issues and develop mitigation plans.
• Be trained as a lead investigator, deviation assessor and approver, and act as a technical reviewer for investigations; approve deviation investigations as technical or quality approver, including minor and moderate deviations.
• Lead complex investigations as needed.
• Ensure procedures, tools, and templates are in place for consistency and sustainability.
• Participate in plant/site CAPA effectiveness program evaluation and ensure trends are identified and investigated to prevent recurrence.
• Coach individuals on inspection interactions and collaborate in regulatory inspections, assisting in preparation of quality topics for audit and inspection readiness.
• Maintain a safe work environment and support all HSE corporate and site goals.

• Bachelor’s degree or Master’s…