Associate Quality Assurance - Compliance

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 – Compliance supports the performance of the site’s Quality Management System (QMS) which enables the organization to provide safe and effective products and to meet customer expectations and regulatory requirements.

The Senior Associate, Quality Assurance – Compliance is responsible for monitoring execution of the site’s QMS metrics (e.g., deviation metrics, change management, CAPA) ensuring that a feedback loop exists to improve business processes and ensure key business objectives are met. The individual in this role represents Quality Assurance on projects associated with driving improvements in the QMS (e.g., LKC QMS transition strategy). The QA Compliance Rep is also responsible for execution of some aspects of QMS such as stability study administration and procedure management.

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 site’s Quality Management System.
• Facilitates the site governance boards (e.g., deviation review board, change review board) as required to ensure adherence with both local and global requirements.
• Compiles and presents QMS program health metrics (e.g., deviation, change control, procedure) to the Site Quality Lead Team with proposed actions.
• Ensures that QMS periodic monitoring reports (e.g., deviation, complaints, management review, equipment) are completed according to established timelines.
• Partner cross-functionally with all area/function owners to review data sources that identify existing as well as potential problems and propose continuous improvement.
• Manages site technical writers and coordinates procedure creation and update.
• Authors, reviews, and/or approves non-conformance investigations, change controls, procedures, site impact analyses, and other GMP documents as required to ensure regulatory compliance.
• Administers the site stability program from a QA perspective.
• Manages the site stability program including creation of stability studies in Darwin, ensuring alignment of study execution with the 3rd party contract laboratory.
• Manages stability studies initiation, ongoing study monitoring and data provided (pull) in support of annual reporting activities to FDA and annual product review process.
• Provides stability data and stability reports in support of analytical investigations and deviations.
• Collaborates with QC Labs and QA for QC resources in investigations related to stability studies.

Basic Requirements:

• Bachelor's degree in a science, engineering, or pharmaceutical-related field of study or equivalent experience.
• Minimum 5 years in the pharmaceutical industry with specific QMS oversight experience.

Additional Skills/Preferences:

• Demonstrated understanding of cGMP regulations.
• Previous experience in GMP production environments.