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Lilly Medical Quality Representative P1-P4 in Austin, Texas

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 35,000 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.

Purpose:

Function as a quality advocate for the assigned area of responsibility who works with management and the quality team to implement a strategy to strengthen quality of medical research by integrating quality into business processes.

Primary Responsibilities:

1. Functional and Technical Expertise

  • Supports the Safety and Efficacy Quality System (SEQS) implementation and education of the business. Participates in SEQS procedure development and in Change Control as appropriate

  • Functions as the initial point of consultation for the business on SEQS related question

  • Responsible for providing input and feedback on quality standards and expectations

  • Consultants on regulations and guidelines; provides interpretation, direct input into quality systems and defines the quality direction to comply with external and internal expectations. Informs and interprets changes in local, regional and global regulations

  • Provides guidance and consultation to the business to enable execution of external and internal regulations on a local, regional and global level to , ensure compliance and inspection readiness

  • Provides input into Global Quality Auditing and Compliance (GQAAC) audit plans and regional and/or affiliate quality plans based on identified signal/risks/gaps

  • Defines, executes and documents quality self-assessments/self-inspections throughout the clinical development process and discusses output with business partners

  • Discusses output of quality self-assessments with business partners, provide recommendations on corrections and corrective and preventative actions (CAPA) and monitor through to resolution

  • Supports and educates the business in developing robust CAPA, deviation management, root cause investigation, audit response management and inspection response management

  • Reports issues through Notification to Management (NTM) as appropriate

  • Participates in the development and implementation of the quality strategy for the Portfolio and for business partners

  • Conducts process reviews based on quality data and trends and shares results with the business

2. Inspection Readiness and Inspection Management

  • Leads pre-inspection preparation activities in collaboration with business partners

  • Prepares and educates internal and external customers/business partners (including investigator site staff) on inspection management

  • Actively supports site and sponsor inspections

  • Responsible for inspection response management and tracking through resolution

  • Coordinates audit responses including Trackwise system documentation

  • Functions as an expert in CAPA management

  • Actively participates in lessons learned/shared learning sessions regarding clinical trial site support during inspections

3. Quality Decision Making

  • Uses a risk based approach for effective communication to influence business decisions

  • Provides feedback to the business on the benefits and risks associated with an issue and/or business solution

4. Influence Quality Direction

  • Collaborates with other quality groups as appropriate and develops a quality network

  • Collaborates with compliance as appropriate and develops a working partnership

  • Shares key learning to drive simplification and replicate best practices

  • Actively participates in team and supported business area meetings

  • Consults on deviation management and root cause analysis

  • Utilizes quality experience to support change management and business transformation in the delivery of the portfolio

5. Problem Solving

  • Support business partners in the resolution of issues

  • Supports business partners in the escalation of issues including the escalation to leadership

  • Anticipates the broader impact of an issue

6. Quality Technical Leadership

  • Initiates, drives and coordinates quality improvement initiatives

  • Shares key learnings and drives quality into the business

7. Project Management

  • Supports the implementation of harmonization of best practices, process improvements and provides feedback on effectiveness of implementation, challenges and best practice

  • Supports local, regional and global medical teams working on key projects

Minimum Qualification Requirements:

  • Bachelor’s Degree in a science/technology/health care related field or equivalent work experience

Other Information/Additional Preferences:

  • Ability to travel to clinical trial sites as required

  • Demonstrated ability to apply quality systems within a regulated work environment

  • Previous experience supporting clinical trials as a Study Coordinator or a Clinical Research Associate

  • Effective project and time management skills

  • Demonstrated ability to communicate effectively, both written and verbal, and to influence others

  • Demonstrated ability to prioritize and handle multiple concurrent tasks

  • Cognitive abilities which include problem solving, verbal reasoning, attention to detail, critical thinking and analytical competencies

  • Strong interpersonal skills with demonstrated flexibility in varying environments/geographies

  • Effective organization/self-management skills

Lilly currently anticipates that the base salary for this position could range from between $58,000 to $152,000 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. 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).Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, 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.

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.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company. If you would like to request an accommodation for medical or religious reasons, you may do so at workplace_adjustment@lilly.com.

At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people.​ We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!

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