Associate - QA Compliance – CSV and DI

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.

Position Description:

The QA Compliance – CSV and DI role is essential in ensuring that assigned functional areas, projects, and systems comply with corporate Computer System Validation (CSV) standards. This position is responsible for maintaining the life cycle management of computer systems, ensuring data integrity, and staying informed about both corporate and external standards related to CSV and Data Integrity (DI). A successful candidate will collaborate effectively with functional area data experts to anticipate and resolve key data management and integrity issues. They will drive solutions that not only impact the site but also align with corporate objectives. This role demands a deep understanding of GMP data flows, both electronic and paper, and the application of data management and integrity principles in operational processes. Additionally, the candidate will utilize Computer System Validation methodologies to ensure regulatory compliance, consistency, and sustainment.

Key responsibilities include ensuring the site’s data integrity training program supports the continuous improvement journey of data integrity. The candidate will also be tasked with enhancing data management standards to ensure data consistency and usability, thereby driving process improvements.

In summary, this role is integral to maintaining the highest standards of data integrity and compliance, ensuring that all processes are aligned with corporate and regulatory requirements.

Key Objectives/Deliverables/Responsibilities:

• Ensure RTP’s computer system program is established and compliant with LQS302 Computer Systems including IDS, Automation, and laboratory computer system lifecycle management programs.
• Review and approve documents per CSV expectations within agreed service levels, or clearly communicate when activities will be completed.
• Acts as site Business QA for the QA Data Systems ensuring data integrity, accuracy, and reliability throughout the data lifecycle.
• Implement and maintain data management processes and systems.
• Serve as a local training instructor for the QA Data Systems.
• Create, revise and approve site compliance area documents, including specifications and procedures.
• Collaborate with cross-functional partners, such as Manufacturing operations, TS/MS (Technical Sciences / Manufacturing Sciences), Engineering, Logistics, Automation, IT, and QC Labs, to streamline processes and sustain customer service
• Investigate non-conformances associated with QA data systems.
• Approve GMP documents (examples: Minor non-conformances, procedures and change controls).
• Analyze large data sets, identify trends and patterns, informing decision making and improving quality processes. Generate regular and ad-hoc reports to document compliance status and findings.
• Create visual representations of data to communicate insights and the compliance status of the Site Quality Metrics to the Site Leadership Team.
• Facilitate Site Quality Metrics reviews within Site Quality Lead Team.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

Basic Requirements:

• Bachelor's degree in engineering, computer systems, or science-related field
• At least 3 years of work experience in the pharmaceutical or medical device industry in QA, CSV, or DI roles.
• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Preferred attributes but not required:

• Proficiency with GMP computer systems validation including regulations governing them
• Previous CSQA / CSV experience
• Demonstrated strong oral and written communication and interpersonal interaction skills
• Demonstrated strong technical writing skills
• Ability to compile/analyze data and metrics in reports understandable by management and business partners.
• Attention to detail, self-management, problem solving; mentoring.
• Previous experience with Quality management systems including TrackWise and Veeva.
• Previous experience with device and parenteral product materials
• Previous experience with deviation and change management systems including TrackWise/Veeva

Other Information:

• Ability to work 8-hour days – Monday through Friday is required on site; up to 4 days per month (e.g. 1 day per week) may be WFH applicable. 
• May require support outside of regular schedule (weekend days or off-hours) in support of continuous (24/7) manufacturing operations. 
• Ability to travel up to 5% to Indianapolis, IN for meetings and coordination with global regulatory organizations is required. 

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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

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.

#WeAreLilly