Principal Associate, Quality Assurance – One-QMS

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 Principal Associate, Quality Assurance – One-QMS serves as the site lead overseeing the Quality Management System (QMS) for Central Quality Systems which enables the organization to provide safe and effective products and to meet customer expectations and regulatory requirements.   

The Principal Associate, Quality Assurance – One-QMS is responsible for improving business processes and supporting site manufacturing stakeholders to ensure key business objectives are met. The Principal Associate – QA Compliance One-QMS Steward represents Quality Assurance on projects, including lean initiatives. Finally, the QA Compliance One- QMS Steward is responsible for activities that include non-conformance investigations, change controls, procedure revisions, site impact analysis reviews, review and approval of cGMP documents, and maintaining regulatory compliance of the Central Quality Systems (CQS).

Responsibilities:

• Implement and maintain the LKC Quality Management System overseeing Deviations, CAPA, Batch Release, Change Control, and Product Complaint management
• Effectively manage the transfer of Quality Management System (QMS) from TrackWise platform to the Veeva platform for the LKC site.
• Collaborate regularly with the global One-QMS team to understand key deliverables and assist in their effective execution for the LKC site.
• Compile and present the progress report for the One-QMS initiative to the LKC Site Quality Lead Team and Site Flow Teams with actions, timelines on a routine basis
• Act as Power User / Site Instructor for the new One QMS Veeva system and for programs within the system such as deviations, Change Controls and CAPA.
• Authors, periodic reviews, and acts as Subject Matter Expert for LKC One-QMS Veeva System.
• Support and initiate Veeva Trend, RCI’s, Tasks or other technical investigations, as applicable.
• Engage with site personnel in coaching and mentoring for the One QMS Veeva system and drive product/process improvements and understanding.
• Support the LKC One-QMS Program owners through facilitation of Senior leadership review boards, Deviation review board, Change review board, Management Review and Execution of records.
• Partner cross-functionally with all area/function owners to review data sources that identify existing as well as potential problems and propose continuous improvement.

Basic Requirements:

• Bachelor’s degree in science, engineering, computer, or pharmaceutical related field of study.
• 5+ years working in the pharmaceutical or medical device industry in QA roles.
• On-site presence required.

Additional Skills/Preferences:

• Proficiency with GMP computer systems including Deviation Management systems, and Document Control systems.
• Advanced Technical Proficiency and understanding of end-to-end operations of quality systems within Deviations, CAPA, Batch Release, Change Control, and Product Complaint management
• Previous process leadership, people influencer experience
• Knowledge of regulatory requirements (e.g., cGMP, 21CFR820, ISO13485, Canadian MDR)
• Demonstrated strong oral and written communication and interpersonal interaction skills
• Demonstrated strong technical writing skills.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
• Previous experience in leading and driving local/global project implementations
• Previous regulatory inspection readiness and inspection execution experience.
• Ability to compile data and metrics in reports understandable by management and business partners.
• Attention to detail, self-management, problem solving; mentoring.
• Previous experience with Quality management systems including TrackWise and Veeva.
• Previous experience with device and parenteral product materials

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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