Team Lead - QC Devices

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 35,000 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.

Organization Overview:

Indianapolis Device Manufacturing (IDM) is responsible for the development, commercialization, manufacture, and global technical stewardship of delivery devices used to administer many of the therapeutics in Lilly's portfolio. This includes the development and delivery of test systems and test methods in support of design verification, production, and complaint handling.

Responsibilities:

The Team Lead provides direction and/or conducts an area's daily workload planning, compliance, and overall customer service. The Team Lead must be committed to personnel interactions (approachable), and will spend considerable time as a mentor/supporter of reporting staff. The Team Lead is also responsible for coordinating laboratory analysts' performance planning.

• Lead, develop, and coach direct reports
• Perform Human Resources Management for all direct reports
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals
• Provide technical understanding of the regulations applicable to laboratory testing for cGMP purposes
• Enforce compliance to all procedures, methods, and other regulatory commitments
• Maintain a high level understanding of the analytical laboratory processes
• Ensure laboratory inspection readiness
• Proactively manage laboratory schedule and priorities by providing direction and resources to support test requests, studies, investigations, etc.
• Coordinate IDM QCL Daily Management System (DMS) activities, including daily huddle, Gemba walks, and Leader Standard Work
• Coordinate IDM QCL 5S activities
• Coordinate safety walkthroughs of IDM QCL
• Strengthen partnerships within IDM, Product Engineering, DDCS, Lilly sites, and contract manufacturers
• Provide project management prioritization and leadership of site initiatives and technical agenda
• Coordinate analytical investigation, observation/deviation, and change control processes within IDM QCL
• Engage project teams, prioritize tasks, manage deliverables, and resolve/escalate issues
• Communicate project status updates to management as required
• Lead and facilitate team continuous improvement efforts to identify opportunities to improve existing business processes

Basic Requirements:

• 3+ years of experience working in a regulated environment or manufacturing
• Demonstrated leadership capability and good interpersonal skills
• Ability to coach and mentor
• Bachelor's degree or demonstrated equivalent experience; emphasis on quality control laboratory operations and/or device testing preferred.

Additional Skills/Preferences:

• Excellent written and oral communications skills including technical writing
• Ability to work across boundaries
• Experience in drug delivery systems and technologies (e.g. pre-filled and re-usable devices)
• Understanding of analytical test system and test method requirements for drug delivery devices
• Understanding of GMP and ISO requirements relative to drug delivery systems

Additional Information:

• Domestic and international travel may be required (< 10% - limited).

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( [email protected] ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.

#WeAreLilly