Lilly
Healthcare
AssociateDirector-QualityAssurance-DeviceAssembly
Neural analysis suggests this role is
optimal for Director candidates.
“Associate Director - Quality Assurance - Device Assembly at Lilly. Skills: Quality Assurance, Device Assembly, Pharmaceutical Manufacturing. Staff quality assurance group. Train quality assurance group”
Industry & Context.
Problem-solving; Decision-making
Ability to travel, Short Term Assignment
What They're Looking For.
Must Have
Bachelor's degree in science, engineering, or pharmaceutical-related field, Minimum 5 years pharmaceutical leadership with QA experience, Minimum 5 years supporting pharmaceutical manufacturing operation, On-site presence required
Nice to Have
Knowledge of Quality Management Systems, Regulatory inspection readiness experience, Regulatory inspection execution experience, Facility or area start up experience, Equipment qualification experience, Process validation experience, Experience with SAP or other inventory management systems, Experience with highly automated combination products, Experience with packaging operations, Experience with warehouse operations, Experience with Manufacturing Execution Systems, Experience with electronic batch release, Experience with automated material movement, Experience with deviation and change management systems, Technical aptitude, Ability to train and mentor others, Demonstrated technical writing skills, Demonstrated problem-solving skills, Demonstrated decision-making skills
What You'll Do.
Staff quality assurance group
Train quality assurance group
Lead quality assurance group
Support facility start-up
Provide quality oversight
Support process development
Support operational readiness
Support qualification
Build quality culture
Ensure robust oversight
Support ongoing operation
Support site inspection readiness
Develop site organization
Create Quality Management System implementation plan
Execute site quality operations
Ensure safe work environment
Develop operational readiness plan
Develop quality processes
Approve operational procedures
Build diverse site organization
Ensure compliance with procedures
Foster quality culture
Maintain open communications
Promote employee participation
Supervise team members
Ensure fair work environment
Achieve results through others
Deliver according to plan
Manage multiple priorities
Deliver in fast-paced environment
Demonstrate flexibility
Respond quickly to changes
Partner with production
Partner with design organization
Ensure 24/7 Quality oversight
Support Operational Excellence initiatives
Continuously improve operation
Review GMP documentation
Approve GMP documentation
Approve qualification protocols
Approve validation reports
Approve technical reports
Approve change controls
Network with global sites
Network with other DA sites
Understand best practices
Work cross-functionally
Support area process teams
Conduct metrics reviews
Provide operational support
Manage issue resolution
Manage deviation resolution
Set area human resource goals
Set business plan goals
Participate in tactical planning
Participate in strategic planning
Communicate project status
Communicate production status
Define inspection readiness activities
Lead inspection readiness activities
Support inspection readiness activities
Interact with Regulatory agencies
Interact during inspections
How You'll Work.
Team & Collaboration
Cross-functional group; Production and design organization; Area process teams; Flow teams
Communication Scope
Written communication; Oral communication
Process & Methodology
Quality Management System implementation
Full Job Description
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 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. . **Position Overview** Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for experienced quality assurance leaders to support our growth in Kenosha County, Wisconsin. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies. The Associate Director, Quality Assurance (QA) – Device Assembly (DA), is 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 is responsible for quality oversight of process development, operational readiness, qualification, and validation of the facility and its associated equipment. The Associate Director will help build a strong quality culture at the site and lead the QA team ensuring robust oversight and support of the ongoing operation as well as the site inspection readiness agenda.
Applying for this Associate Director - Quality Assurance - Device Assembly role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about Lilly?
Real rants from real employees. Read before you apply.