Associate Director - Site Quality - Distribution

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 serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

The Site Quality Leader (SQL) for Logistics Operations serves as the site quality leader role for the organization.  The SQL assures that the quality system is implemented effectively and that processes are in place to assure the quality of Lilly products throughout the distribution process.

Responsibilities:

• Ensures the operations are in compliance with applicable Quality Standards and Quality Practices

• Applies knowledge of quality principles and cGMPs toward the development of local procedures

• Exhibits critical business decision-making bringing about successful results; assures all quality related decisions are made in alignment with cGMPs and Lilly quality expectations

• Plays the leadership role in implementation of quality systems

• Defines and monitors the quality plan to ensure proper priority, resources, and direction have been provided

• Assures continual Quality improvement and regulatory compliance across all operations; leads the development of improved and streamlined quality systems

• Coordinates and manages regulatory inspections, defines and maintains inspection readiness activities, and interacts with regulatory agencies during inspections regarding cGMP issues

• Participates on the NALO Lead Team, Quality Lead Team and Distribution Review Board; works collaboratively with NALO Operations to ensure development of systems that will facilitate streamlined workflow

• Networks with other areas to understand best practices and share knowledge, participates in tactical and strategic business planning, and ensures customer needs are met

• Participates in Human Resource Development, Human Resource Planning, and Performance Management plans for direct reports; recruits new talent

• Communicates to and strives for integration of support groups outside of the plant; serves as a conduit for Corporate communications

• Networks with other sites regarding new systems development

• Develops plan for capital purchases

• NALO Device Management Representative dotted line reporting to PDS/IDM Management Representative in compliance with ISO13485:2016 section 5.5.2.

• Responsible for ensuring data integrity and good documentation practices while performing job tasks

Basic Qualifications / Requirements:

• BS or equivalent in a scientific field

• Minimum of 5 years experience in Production, Quality Control, Quality Assurance, or Technical Services

Additional Preferences:

High-quality skills including:

• Ability to prioritize and to make critical decisions

• Written and oral communication

• Interpersonal/people skills, mentoring/leadership

• Computer applications

• Problem solving

• Self-motivation

• Leads the way for ensuring a fair and equitable work environment

• Clear understanding of all cGMPs policies, procedures, and guidelines

Additional Information

This is not a remote position and requires on site presence

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 an EEO/Affir