Senior/Principal - Complaint Management QA

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.

Specific functions, duties, or tasks:  

• Review and approve complaint investigations for devices, drug/device combination products. 
• Initiate and support Trend, RCI’s, Review Management, Change, Deviation, or other technical investigations, as applicable 
• Conduct complaint history reviews
• Compile and document ad-hoc reports, as needed 
• Understand the devices and drug/device combination products to support investigations as defined in Lilly procedures.  
• Support activities associated with device safety surveillance for both devices and drug/device combination products 
• Collaborate, participate in projects, and provide customer service for groups external to IDM, including, but not limited to, Regional Centers, OUS Affiliates, Global Patient Safety, CPQA, DPEM, and component suppliers as needed 
• Review / write / approve GMP documents including SOPs, global training, global procedures/non-method procedures, technical reports, and process level procedures and training, as applicable 
• Support continuous improvement projects and new launches as needed 
• Participate in project work that requires substantial technical knowledge and continuous improvement skills 
• Utilize non-routine software tools or business systems to gather data and provide metrics on device complaint issues or complaint process efficiency 
• Verify action records, effectiveness checks, and implementation reviews✓
• Conduct Second Person Verification for reports as needed. 
• Network within and outside of IDM to identify and implement opportunities for improvement and/or transfer of IDM or complaint handled best practices to other business partners.

 

Minimum Experience Qualification Requirements:

• Minimum of three years industry experience in areas which may include Quality, Engineering, Development or Manufacturing/Packaging
• Technical knowledge in design, manufacturing or validation; preferably devices
• Technical knowledge of complaint handling and/or quality systems; preferably devices
• Knowledge of regulatory requirements (e.g., cGMP, 21 CFR 820, ISO13485, Canadian MDR)
• Strong computer literacy in Outlook and Microsoft
• Strong competency in English
• Technical Writing Skills

Additional Preferences:

• Basic knowledge in statistics and its applications
• Ability to compile data and metrics in reports understandable by management and business partners
• Attention to detail; self-management; problem solving; mentoring

Minimum Education Requirements:

• Bachelor’s degree in Engineering, Medical or Life Sciences preferred

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 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.

#WeAreLilly