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
$63,000 - $162,800
Organization Overview
At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world’s greatest health challenges.
Purpose: We are seeking a Medicines Quality Representative (MQR) to join our MQO Biometrics team. The purpose of this role is to partner with Statistics, Data and Analytics as their quality expert. The MQR will actively participate in strategic planning to strengthen the quality of Medical Research, Safety and Efficacy Quality System (SEQS) effectiveness, and the integration of quality into business processes. They will also be responsible for implementing quality initiatives and providing guidance to teams using risk-based decision making with a focus on data integrity. Information for Internal Employees: This is a technical path (R path) role within the M&Q Technical Ladder process. The successful candidate will be hired at their current level and would be eligible for future promotions in accordance with the M&Q Technical Ladder process.
Primary Responsibilities: 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. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
- Ensure compliance with internal guidelines and external regulations
- Provide guidance to the Statistics, Data and Analytics business to enable execution of regulations on a local, regional, and global level
- Execute continuous inspection readiness principles and participate in inspection management efforts
- Influence direction of quality decisions through partnering with cross-functional Research & Development teams and other global Quality personnel
- Solve problems related to quality assurance
- Provide quality technical leadership related to the scope of Statistics, Data and Analytics deliverables
- Manage projects related to quality assurance
- Focus on customers and external stakeholders
Basic Qualifications:
- Bachelors Degree in statistics, a life science or data science, technology or medically-related field
- 3+ years of experience in Pharmaceutical Research and Development and/or Quality
Additional Preferences:
- Statistics or Data Management experience
- Global perspective and working across functional and geographical boundaries
- Knowledge of Clinical Development and GxP regulations, guidelines and standards
- Demonstrated understanding of quality management system principles, including policies, procedures and processes
- Demonstrated ability to identify root cause, manage difficult global business/quality issues, and separate critical from non-critical issues
- Knowledge of the international regulatory framework
- Ability to influence, negotiate and project manage
- Ability to work effectively at all levels of the organization
- Excellent problem solving skills and initiative
- Proficient written and spoken English language skills
- Effective verbal communication
- Demonstrated inclusive, team-focused behaviors
- Master’s Degree or PhD
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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What We Do
Eli Lilly and Company engages in the discovery, development, manufacture, and sale of products in pharmaceutical products business segment.
For more than a century, we have stayed true to a core set of values – excellence, integrity, and respect for people – that guide us in all we do: discovering medicines that meet real needs, improving the understanding and management of disease, and giving back to communities through philanthropy and volunteerism.
