Associate Director - Quality Assurance - Device Assembly

BioSpace; Pleasant Prairie (WI); On-site; USD 123,000 - 198,000; Full time

Benefits offered by this job

Flex hours

On-site primary location Kenosha, WI

Travel opportunities (10-20%)

Job summary

Lilly is expanding its quality assurance leadership for device assembly at the Kenosha site in Wisconsin. The Associate Director, QA – Device Assembly, will staff and mentor the QA group, oversee process development, qualification, and validation, and ensure inspection readiness and regulatory compliance.

This role emphasizes building a robust quality culture, cross-functional collaboration, and strong oversight of GMP documentation while supporting a 24/7 operation and 10–20% travel.

Qualifications

• Bachelor's degree in science, engineering, or pharmaceutical-related field or equivalent experience.
• Minimum 5 years’ experience in pharmaceutical leadership with QA experience, including cross-functional collaboration.
• Minimum 5 years’ experience directly supporting pharmaceutical manufacturing operations (device assembly preferred).
• On-site presence required.

Responsibilities

• Lead QA team during start-up of device assembly and packaging (DAP).
• Develop and approve QA processes, qualification, validation, and inspection readiness.
• Maintain GMP documentation and ensure compliance with area procedures and controls.
• Foster a strong quality culture and open communication across teams.
• Collaborate with production and design to ensure 24/7 QA oversight and support.
• Manage multiple priorities in a fast-paced environment to meet due dates.

Skills

QA Leadership

Cross-functional Leadership

Regulatory Knowledge

GMP Documentation

Quality Systems

Device Assembly Operations

Education

Bachelor's degree in science/engineering/pharma

Tools

SAP

Manufacturing Execution Systems (MES)

Veeva

Electronic Batch Release systems

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Organization 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. .

Position Overview

Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for experienced quality assurance leaders to support our growth in Kenosha County, Wisconsin. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies.

The Associate Director, Quality Assurance (QA) – Device Assembly (DA), is responsible for staffing, training, and leadership of the quality assurance group supporting the start‑up of combination product device assembly and operations at the Kenosha site. This individual is responsible for quality oversight of process development, operational readiness, qualification, and validation of the facility and its associated equipment. The Associate Director will help build a strong quality culture at the site and lead the QA team ensuring robust oversight and support of the ongoing operation as well as the site inspection readiness agenda.

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.

Basic Requirements

• 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

Additional Skills/Preferences

• 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 skillsStrong technical aptitude and ability to train and mentor others
• Demonstrated technical writing skills
• Demonstrated problem‑solving and decision‑making skills

Additional Information

• Flex hours possible
• Primary location is Kenosha, Wisconsin
• Ability to travel (approximately 10-20 %)
• Ability for Short Term Assignment (6-9 Months) in a Device Assembly and Packaging site prior to starting the role

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$123,000 - $198,000

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including 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; and well‑being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly