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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$118,500 - $173,800

Organization Overview:
The Associated Director - Quality Compliance role is part of the Lilly Pharmaceutical Delivery Systems (PDS) Quality Systems and Regulatory Compliance Team. The team provides support and oversight of the Lilly Indy Device Manufacturing (IDM) and PDS devices network of global sites and internal/external suppliers.

Responsibilities:

The Associate Director - Quality Compliance will have responsibility for leadership of the auditing, learning and development, and purchasing controls functions within the Indy Device Manufacturing team. As part of the internal/external audit and site self-inspection programs, the audit team performs audits of both internal IDM functions and internal and external PDS suppliers/contract manufacturers to provide oversight of these areas and organizations and ensure compliance with governing standards and regulations. The position oversees the learning and development team, which is responsible for implementation of procedures, training, and associated learning management system administration across the IDM site and associated resources. Further, this position is responsible for execution of the Purchasing Controls and Supplier Management Quality System and associated resources.

Ensure an adequate number of qualified resources are available to perform quality assurance activities in support of IDM Quality operations and oversight of quality compliance activities to include auditing, learning and development, and purchasing controls functions

Ensure adherence to the quality policy and objectives for the site

Provide technical understanding and internal/external communication (throughout various functions and organization levels) regarding the Quality Management System to ensure on-going management of quality system requirements in order to maintain compliance and drive continuous improvement activities

Participate in and respond to regulatory agency and self-inspections internal to IDM as well as providing support to quality audits

Manage internal/external audit and site-self inspection resourcing, alignment with corporate auditing function, where applicable

Responsible for development and maintenance of IDM Purchasing Controls and Learning & Development systems

Review/approve or reject procedures and training, change proposals, purchasing controls documentation, deviations, and ensure implementation of appropriate corrections/CAPA and effectiveness checks

Mentor, coach and provide feedback to team members and cross-functional partners

Collaborate to drive and influence continuous improvement impacting compliance and operational excellence, including through support of network and functional initiatives

Participate in organizational and business planning activities

Exhibit cross-functional influence

Aid in human resource planning, development and performance management for direct reports

Other duties as required

Basic Requirements:

Bachelor’s Degree (or equivalent work experience)

Minimum of five (5) years industry related experience in areas which may include Quality, Technical Services, and/or ManufacturingExperience with governing standards and regulations (e.g., 21CFR Part 4, Part 11, Parts 210/211, Part 820 QSR, ISO 13485, ISO 14971, Canadian MDR, EU MDR, JPAL)
Additional Skills/Preferences:Demonstrated leadership capabilityDemonstrated interpersonal skill for working with cross-functional teams, suppliers and contract manufacturersAbility to influence diverse groupsDemonstrated oral and written communicationDemonstrated self-management/time-management skillsDemonstrated ability to meet commitments and deadlinesDemonstrated decision-making and problem-solving skillsAbility to work as part of a teamDemonstrated negotiating coaching and mentoring skillsExperience with regulatory inspectionsExperience with quality auditing, Learning and development, and/or purchasing controlsTechnical knowledge in Quality System elements, devices/combination products, design/development, and manufacturing
Additional Information:This position requires approximately 5-10% travel.

This position is hybrid and is based in Indianapolis, Indiana

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/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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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