Associate Director - Quality Assurance - Device Assembly

Position Overview

Associate Director, Quality Assurance (QA) – Device Assembly (DA) – 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 oversees quality of process development, operational readiness, qualification, and validation of the facility and its equipment, fosters a strong quality culture, and leads the QA team to bring robust oversight for ongoing operations and inspection readiness.

Responsibilities

• Support the Sr. Director, QA, in developing the site organization, creating the Quality Management System implementation plan, and executing site quality operations in Device Assembly and Packaging (DAP).
• Ensure a safe work environment, supporting and leading safety efforts for the quality team.
• Develop the overall site operational readiness plan, including quality processes and approval of operational procedures for DAP.
• Build a diverse site organization to provide quality oversight, ensuring compliance with area procedures and controls for device assembly.
• Foster a strong quality culture with open communication and teamwork, promoting employee participation.
• Supervise, coach, and aid in development and performance management for a fair and equitable work environment.
• Engage the team and delegate to achieve results and 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 to changing priorities or emerging issues.
• Partner with production and design organization to ensure 24/7 quality oversight and support.
• Engage and support Operational Excellence initiatives for monitoring performance and continuous improvement.
• Review and approve GMP documentation—including qualification/validation protocols and reports, procedures, deviations, technical reports, and change controls—for DA operations.
• Network with global and other DA sites to understand best practices and share knowledge.
• Work cross‑functionally with area process teams 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 or equivalent experience.
• Minimum 5 years’ experience in pharmaceutical leadership with QA focus, leading or working effectively with cross‑functional groups.
• 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 skills.
• Strong 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: 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.

Compensation and Benefits

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 employees are also eligible for a company bonus (depending, in part, on company and individual performance) and a comprehensive benefit program to eligible employees, including 401(k) participation, pension, vacation, medical, dental, vision, prescription drug benefits, flexible benefits (e.g., health and/or dependent day care FSA), life insurance, death benefits, time‑off and leave of absence benefits, and well‑being benefits such as employee assistance program and fitness benefits.

EEO Statement

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.

Accommodation Statement

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce. If you require accommodation to submit a resume for this position at Lilly, please complete the accommodation request form at careers.lilly.com/us/en/workplace-accommodation for further assistance.

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