Eli Lilly and Company · 7 hours ago
Associate Director - Quality Assurance - Device Assembly
Pleasant Prairie, WI
Full-time
Onsite
Lead/Staff, Director/Executive
$123K/yr - $198K/yr
5+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to making life better for people around the world. The Associate Director of Quality Assurance will lead the quality assurance group for device assembly operations, ensuring compliance and operational readiness while fostering a strong quality culture at the site.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Support the Sr. Director, QA, in the development of the site organization, creation of the Quality Management System implementation plan, and execution of site quality operations in Device Assembly and Packaging (DAP)
Support the site to ensure a safe work environment including supporting and leading safety efforts for the quality team
Support the development of the overall site operational readiness plan including development of quality processes and approval of operational procedures for DAP
Build a diverse and capable site organization to provide quality oversight and ensure compliance with area procedures and controls for device assembly
Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group
Supervise, coach, and aid in development, performance management, ensure a fair and equitable work environment
Engage team and delegate to achieve results through others to deliver according to plan
Manage multiple priorities in a fast-paced environment and deliver in accordance with established due dates
Demonstrate flexibility with quick response as priorities change or issues arise
Partner with production and design organization to ensure 24/7 Quality oversight and support
Engage and support Operational Excellence initiatives for monitoring performance and continuously improving the operation
Review and approve GMP documentation including qualification/validation protocols and reports, procedures, deviations, technical reports, change controls, for DA operations
Network with global and other DA sites to understand best practices, share knowledge
Work cross-functionally with the area process teams/flow team for metrics reviews, operational support, and issue/deviation management
Set area human resource and business plan goals
Participate in tactical and strategic business planning
Communicate on project and production status
Define, lead and/or support inspection readiness activities for operations and interact with Regulatory agencies during inspections
Qualification
Required
Bachelor's degree in a science, engineering, or pharmaceutical-related field of study or equivalent experience
Minimum 5 years' experience in pharmaceutical leadership with QA experience, including leading or working effectively with a cross-functional group
Minimum 5 years' experience directly supporting a pharmaceutical manufacturing operation (preferably device assembly operations)
On-site presence required
Preferred
Strong knowledge of Quality Management Systems and applicable regulatory requirements
Previous regulatory inspection readiness and inspection execution experience
Previous facility or area start up experience
Previous equipment qualification and process validation experience
Previous experience with SAP or other inventory management systems
Previous experience with highly automated combination products, packaging, and warehouse operations
Previous experience with Manufacturing Execution Systems and electronic batch release
Previous experience with automated material movement (central palletizing operation, automated warehousing)
Previous experience with deviation and change management systems such as Veeva
Excellent interpersonal, written and oral communication skills
Strong technical aptitude and ability to train and mentor others
Demonstrated technical writing skills
Demonstrated problem-solving and decision-making skills
Benefits
Company bonus
Eligibility to participate in a company-sponsored 401(k)
Pension
Vacation benefits
Eligibility for medical, dental, vision and prescription drug benefits
Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
Life insurance and death benefits
Certain time off and leave of absence benefits
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
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2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
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