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.
Organization Overview:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism
Responsibilities:
The QA Materials Disposition Sr. Manager will report to the Associate Director Quality (Materials). The QA Materials Disposition Sr. Manager manages, develops, and provides guidance to the incoming disposition team. This person is essential to support activities related to release of incoming materials utilizing SAP.
Key Objectives/Deliverables:
- Practices safety behaviors with proper PPE and lifting techniques. Supports all HSE Corporate and Site Goals.
- Support the site in the development and execution of the site readiness plan with focus on supporting development of the site e-release process
- Manage a team of QA incoming batch disposition associates
- Responsible for ensuring team is trained and training remains in compliance.
- Ensuring materials not meeting specifications are quarantined, per local procedures.
- Ensure materials are released in a timely manner, as to not delay production.
- Evaluating temperature excursions on shipments received at the warehouse.
- Performs appropriate transactions in SAP to ensure system represents appropriate status of material (QI, blocked, scrapped, etc.)
- Performs final disposition of incoming materials
- Initiates complaints/remarks to supplier for materials not meeting Lilly expectations.
- May participate in investigations regarding materials or service complaints.
- Authors/revises SOPs, materials specifications, as needed.
- Interacts with other quality functions and supports material related Supplier Change Notifications.
- Participates in/supports regulatory inspections, as needed.
- Communicates with QA Associate Director Materials and other cross functional peers on quality issues
- Networks with the business and ensures all materials are dispositioned in a timely manner to support production schedule
Basic Qualifications:
- Bachelor's degree in a science, engineering, computer, or pharmaceutical related field of study, preferred
- 5+ years in leadership with specific QA experience, including leading or working effectively with a cross-functional group
- Strong knowledge of Quality Management Systems and applicable regulatory requirements
- Previous batch disposition experience
- Previous pharmaceutical experience
- Previous regulatory inspection readiness and inspection execution experience
- Demonstrated understanding of cGMP practices including good documentation practices, data integrity and regulatory compliance
- Demonstrated ability to communicate with cross-functional teams including good oral and written communication skills
- Strong attention to detail
- Proficient in computer system applications
- Ability to organize and prioritize multiple tasks, highly flexible, and able to work independently in fast paced environment to support production demands
- Excellent interpersonal and networking skills
- Highly motivated, enthusiastic, share ideas and lead solutions effectively to resolution; ensure safety of others.
- Experience in inventory management systems (SAP, EWM, etc.)
Additional Skills/Preferences:
- Previous facility or area start up experience.
- Understanding of statistical tools and analysis.
- Previous experience with Deviation and Change Management process
Additional Information:
- Overtime and off-shift support may be required.
- May be required to respond to operational issues outside of core business hours and days.
- May be subject to post-offer physical and vision exam.
- Job is exposed to repetitive movements such as: Walking, Sitting, Bending, Twisting.
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 specifically described in the job description. For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.
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
$91,500 - $147,400
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.