Associate Director - QA

Eli Lilly and Company • Us, IN

14d

About The Position

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 Associate Director is a member of the Quality Assurance Compliance organization. The purpose of the Associate Director role is to support the development and implementation of the Indianapolis Active Pharmaceutical Ingredient (IAPI) Quality Management System (QMS) and its elements across the site. This includes end-to-end process ownership, oversight and execution of QMS deliverables throughout the QMS life cycle to ensure CGMP compliance with local, global, regulatory and industry requirements. This role collaborates with quality and other site functions to integrate these requirements into the manufacturing operations and support areas.

Requirements

• Bachelor’s Degree in a science/technology/health care related field
• 5+ years of CGMP pharmaceutical experience

Nice To Haves

• Previous QA/QC experience in a CGMP environment
• Demonstrated ability to communicate effectively, both written and verbal, and to influence others
• Demonstrated ability to prioritize and handle multiple tasks concurrently
• Cognitive abilities which include problem solving, verbal reasoning, attention to detail, critical thinking and analytical competencies
• Previous experience leading and implementing projects at a site level is preferred
• Experience in pharmacovigilance
• Ability to present information and concepts at all levels of the organization

Responsibilities

• Assume end-to-end process ownership and oversight of QMS elements at the site (e.g. change management, deviation management, inspection readiness, pharmacovigilance)
• Provide coaching, mentoring, training and technical expertise to the site as the Subject Matter Expert (SME) for any given QMS process
• Tabulate and facilitate metrics reporting to the Site Lead Team and for monitoring and continuous improvement of the QMS processes
• Provide support for internal and external audits/inspections (e.g. readiness, back/front room support, coordination of inspection responses)
• Lead and/or participate in the site Inspection Readiness Team and its initiatives
• Provide QA support to local regulatory and global affiliates for GMP certification registrations, renewals and submissions
• Stay abreast of latest trends, applications, and compliance requirements. Share trends at site applicable forums and establish strategies/actions for deployment when applicable
• Participate in management review activities of the global quality systems
• Contribute to the development of area specific procedures and supporting documents (e.g. required tools, resource documents and supplemental materials)
• Review and approve quality system related documents

Benefits

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees