Associate Director Data and Systems 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.

Lilly is currently constructing an advanced manufacturing facility for production of Active Pharmaceutical Ingredient (API) molecules located in Lebanon, Indiana, USA. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility, and the culture to enable a successful startup into GMP manufacturing operations.

Job Position Overview:

The Quality Assurance Associate Director of Data and Systems QA provides quality oversight to the validation of computer systems at LP1 along with the Data Management oversight and governance at the site. This person is also the Site Data Leader. The Associate Director is also responsible for managing the development of direct reports and prioritizing work appropriately to implement LP1, Computer System Quality Assurance (CSQA) and Data Management objectives.

Responsibilities:

• Provide direct quality oversight to LP1 computer system validation (CSQA) and assist others in interpretation of regulatory and corporate requirements as it relates to CSQA and data integrity/management.
• Provide quality guidance, technical support and recommendations to efficient CSV and data integrity principles, process issues and continuous improvement initiatives.
• Work as the LP1 Site Data Leader.
• Work with cross functional teams to implement QA objectives.
• Prepare for and participate in internal and external regulatory inspections.
• Coach and mentor Data and Systems QA representatives in aspects of QA support including CSV/Data Management understanding, problem solving, project management and deviation investigation/resolution.

Basic Requirements:

• BS or higher degree in Engineering or science related field
• 5+ years in pharmaceutical manufacturing, with specific experiences to computer system validation and data integrity principles.

Additional Skills/Preferences:

• Previous experience in QA, TS/MS QC or Engineering
• Prior work with cGMPs or external regulations
• Strong knowledge of Computer System Validation, Data Integrity/Management, Quality Management Systems, and applicable regulatory requirements
• Demonstrated problem solving and decision-making skills
• Strong technical aptitude and ability to train and mentor others

Additional Information:

The normal schedule for this position is Monday-Friday, 8 hours/day. However, critical situations may require additional support beyond this normal schedule.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. For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

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 ( 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
$123,000 - $180,400

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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