Sr. Associate, Quality Assurance - CAPA Lead

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.

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 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 associates to support our growth in Lilly Kenosha County (LKC). This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies.

The Senior Associate, Quality Assurance – CAPA Lead serves as the site lead overseeing the LKC Deviation and CAPA program which is part of the overall Quality Management System (QMS) which enables the organization to provide safe and effective products and to meet customer expectations and regulatory requirements.

The QA Compliance CAPA Lead is responsible for collecting and analyzing information to identify actual and potential product and quality problems, to work with the Site Quality Lead Team to take appropriate and effective corrective and preventive actions, and to verify and validate the effectiveness of those CAPA.  The individual in this role will lead the site in driving product and process improvement and enhanced product and process understanding. This position is essential for maintaining GMP compliance and ensuring inspection readiness. 

Responsibilities:

• Maintains responsibility for a safe work environment, leading safety initiatives, and working safely; accountable for supporting all Health, Safety, and Environmental Corporate and Site Goals.
• Leads, mentors, and coaches operations and support personnel on the deviation management system and CAPA program.

• Facilitates the Site Deviation and CAPA review board, providing board leadership to drive complete root cause investigations and ensure assignment of corrective and preventive actions to eliminate the root causes of a detected issue or other undesirable situation to prevent reoccurrence.
• Create and maintain the CAPA program, through working cross-functionally with all area/function owners to include data sources that identify existing as well as potential problems.
• Compile and present CAPA program health metrics to the Site Quality Lead Team with proposed actions.
• Monitor deviation and CAPA performance to ensure investigations and associated CAPA are completed in a timely manner.
• Act as a site instructor for Deviation Management courses.
• Coaches lead investigators on technical writing.
• Authors periodic reviews and acts as Subject Matter Expert for site CAPA and Deviation Management procedures.
• Supports and initiates deviations, trends, or other technical investigations, as applicable.
• Engages site personnel in the relationship between the CAPA program and resulting product and process improvement and enhanced product and process understanding.

• Works with the network deviation program mentor to benchmark and replicate best practices.

Basic Requirements:

• Bachelor's degree required.
• Minimum 5 years in the pharmaceutical industry with specific deviation management and CAPA experience.
• On-site presence required.

Additional Skills/Preferences:

• Demonstrated understanding of cGMP regulations.
• Previous experience in GMP production environments.
• Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of pharmaceutical manufacturing
• Proficiency with applicable computer systems
• Demonstrated strong oral and written communication skills
• Demonstrated interpersonal skills and the ability to work as a team
• Root cause analysis/troubleshooting skills
• Demonstrated attention to detail and ability to maintain quality systems
• Proven ability to work independently or as part of a Team to resolve an issue
• Technical Writing and Communication Skills
• Previous regulatory inspection readiness and inspection execution experience.

Additional Information:

• Primary location is Kenosha County, Wisconsin
• Ability to travel (approximately 10 %)
• Ability to work overtime as required.

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 (https://careers.lilly.com/us/en/workplace-accommodation) 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

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.

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