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. 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.
Position Description:
The Quality Assurance Associate Director is responsible for support of the final quality disposition of materials, semi-finished and finished goods for the RTP production site. The role will help build a strong quality culture and be part of the QA Lead Team responsible for oversight and support of the ongoing operation as well as site inspection readiness and execution. The Associate Director reports to the Site Quality Leader.
Key Objectives/Deliverables:
- Support the site to ensure a safe work environment including supporting and leading safety efforts for your team
- Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group
- Support the development of the overall site operational readiness plan including development of quality processes and approval of operational procedures
- Provide technical and quality review and approval documents to ensure compliance with Lilly Global Quality Standards as well as global and local quality standards and procedures
- Support the Site Quality Leader in the development of the site organization, creation of the Quality Management System implementation plan, and execution of site quality operations in the batch
- Build a capable organization to support quality oversight, and ensure compliance with area procedures and controls for material and product record review and release
- Drive operational excellence in disposition process through data analysis to reduce variability and shift performance cycle times to align with supply delivery targets
- Supervise, coach, and aid in development, performance management, ensure a fair and equitable work environment
- Review and approve GMP documentation including procedures, deviations, technical reports, change controls, etc.
- Support site inspection readiness and execution
- Work cross-functionally with the area process teams for metrics reviews, operational support, and issue / deviation management
- Network with global and Parenteral Quality Network sites to understand best practices, share knowledge, and participate in tactical and strategic business planning
- Interact with the global, project and functional areas to coordinate start up activities to support the overall project and site schedule
- Consult with Network and Global quality groups as required to ensure consistent and compliant approach is executed during the startup phase and into operation
- Setting of area human resource and business plan goals
Minimum Requirements:
- Bachelor's degree in a science, engineering, computer, pharmaceutical related field of study or related technical degree
- 7+ years of experience in QA/QC roles in the pharmaceutical industry
- Previous management or leadership experience including leading or working effectively with a cross functional group
Additional Skills/Preferences
- Strong knowledge of Quality Management Systems and applicable regulatory requirements
- Previous regulatory inspection readiness and inspection execution experience
- Previous experience directly supporting a large manufacturing and warehouse operation
- Previous experience with highly automated manufacturing processes
- Previous experience with Manufacturing Execution Systems and electronic batch release
- Excellent interpersonal, written and oral communication skills
- Strong technical aptitude and ability to train and mentor others
- Ability to work 8-hour days - Monday through Friday
- Ability to work overtime as required
- Ability to travel up to 10% to Indianapolis, IN for meetings and coordination with global regulatory organizations.
- Previous facility or area start up experience
- Previous experience with SAP or other inventory management systems
- Previous experience with deviation and change management systems including Trackwise
- Previous experience with Lean, Six Sigma or other known improvement methodology
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 ( ) 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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$118,500 - $173,800
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.