Sr. Manager - QA Incoming Batch Disposition
Description:
Job Details
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 Manager is responsible for support of the 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 responsible for oversight and support of the ongoing operation as well as site inspection readiness and execution. The Manager reports to the Associate Director-Materials QA.
Key Objectives and 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
Build a diverse and 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
Interact with the project and functional areas to coordinate activities to support the overall project and site schedule
Setting of area human resource and business plan goals
Basic Qualifications
Bachelor's degree in a science, engineering, computer, pharmaceutical related field of study or equivalent experience
Previous experience working in the pharmaceutical industry in QA/QC roles
Previous management or leadership experience including leading or working effectively with a cross functional group
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
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
$91,500 - $134,200
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
Company
Science has been our calling from the beginning. Colonel Eli Lilly founded the company in 1876 and charged employees to "take what you find here and make it better and better." More than 147 years later, we remain committed to his vision through every aspect of our business and the people we serve, starting with discovering the best treatments for those who take our medicines and extending to health care professionals, employees and the communities in which we live. Moreover, you can also count on the team at Lilly to be incredibly civic-minded, supporting our communities through philanthropy, volunteerism, and a creative and innovative can-do spirit.
Company info
Location 893 S Delaware St
Indianapolis
Indiana
46285
United States
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