Deviation Mentor

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.

The Deviation Mentor is a member of the LKC Quality organization that educates, mentors, and guides deviation investigations and analytical investigators. The mentor is responsible for the training program, may lead deviation review boards, participate in deviation assessment reviews pre‑ and post‑approval, and lead site metrics related to the deviation system. They participate in regulatory inspections and collaborate in the inspection readiness program.

• Provide advice and guidance to lead investigators in deviation investigation and analytical investigations (assessment, quality impact evaluation, root cause analysis method), investigation write‑up (technical writing), support data, CAPA establishment and effectiveness.
• Coach the deviation review board: review deviations prior to deviation approval, assist deviation reviewers and approvers on issue investigation matters.
• Owns the elaboration and reviews of deviation trend reports.
• Facilitates the implementation of DRB Playbook at the plants and site level and connects plant/site metrics, trending and procedures with its implementation.
• Establishes linkages with network and global teams and participates in relevant forums, such as global deviation CoP, ensuring 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, and participate in the review of plant deviation trend analysis.
• Integrate global initiatives and/or projects related to the deviation management program into the site quality standards and processes.
• Design and deliver deviations related to deviation management training programs.
• Escalate concerns/issues and develop mitigation plans.
• Trained as a lead investigator, deviation assessor and approver; can act as a technical reviewer for deviation investigations and analytical investigations. Can approve deviation investigations, either as technical or quality approver, including minor and moderate deviations.
• Can lead complex investigations.
• Ensures procedures, tools, and templates are in place (as applicable) for consistency and sustainability.
• Participates on plant/site CAPA effectiveness program evaluation.
• Ensures trends are timely identified and investigated to prevent recurrence.
• Coaches individuals on inspection interactions.
• Collaborates in regulatory inspections, assisting in the preparation of key quality and compliance topics for audit and inspection readiness.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site goals.

• BSc or MSc in a scientific or technical degree (chemistry, biology, microbiology, engineering or equivalent scientific/technical degree).
• 5+ years of experience in deviation management and analytical investigation experience in the pharmaceutical industry, parenteral manufacturing experience preferred.

• Experience in TS/MS, Engineering, QC and/or QA is preferred with expertise on parenteral products manufacturing.
• Excellent technical writing skills.
• Strong influencing skills and interpersonal and teamwork skills.
• Strong self‑management and organizational skills.
• Demonstrated successful cross‑functional teamwork.
• Critical thinking skills.
• Good knowledge of cGMP, external regulations and quality systems requirements.
• Excellent communication skills.

• Primary location is Kenosha County, Wisconsin.
• Onsite presence is required.
• Ability to travel (approximately 10 %).
• Ability to work overtime as required.

The anticipated wage for this position is $115,500 – $184,800.

Full‑time employees also will be eligible for a company bonus (depending on company and individual performance). Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company‑sponsored 401(k); pension; vacation benefits; eligibility for…