Associate Director, Quality Assurance - Parenteral Packaging

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 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 put people first and are looking for people who are determined to make life better for people around the world.

Position Overview

Lilly is actively growing its manufacturing footprint globally to meet patient needs and deliver on our future. We are seeking experienced quality assurance leaders to support growth in Kenosha County, Wisconsin. This is an opportunity to deliver on new manufacturing investments and pioneering technologies.

Associate Director, Quality Assurance (QA) – Parenteral Packaging is responsible for staffing, training, and leadership of the quality assurance group supporting the start-up of combination product device and parenteral packaging operations at the Kenosha site. This role oversees quality for process development, operational readiness, qualification, and validation of the facility and equipment. The Associate Director will help build a strong quality culture and lead the QA team ensuring robust oversight and support of ongoing operations 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 DAP.
• Support the site to ensure a safe work environment including 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 Parenteral Packaging.
• Build a diverse and capable site organization to provide quality oversight and ensure compliance with area procedures and controls for labeling and packaging operations.
• 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, and 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 continuous improvement of the operation.
• Review and approve GMP documentation including qualification/validation protocols and reports, procedures, deviations, technical reports, and change controls for parenteral packaging operations.
• Network with global and other parenteral packaging sites to understand best practices and share knowledge.
• Work cross-functionally with 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 or equivalent experience.
• Minimum 5 years’ experience in pharmaceutical leadership with QA experience, including leading or working effectively with cross-functional teams.
• Minimum 5 years’ experience directly supporting a pharmaceutical manufacturing operation (preferably parenteral packaging 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 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

Notice and Equal Opportunity

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not described herein. For GMP purposes, the description should be updated for significant changes. Consult with your supervisor about actual duties.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce and ensure equal opportunities when applying. If you require accommodation to submit a resume, please complete the accommodation request form. This is for accommodation requests as part of the application process; 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. Learn more about all of our groups.

Actual compensation will depend on education, experience, skills, and location. The anticipated wage for this position is $123,000 - $198,000. Full-time employees are eligible for a company bonus and a comprehensive benefits program including 401(k), medical/dental/vision, flexible benefits, life insurance, leave, and well-being programs. Lilly reserves the right to amend, modify, or terminate compensation and benefits programs at its discretion. #WeAreLilly

#J-18808-Ljbffr