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 plays a critical role in developing and maintaining the quality and regulatory compliance of our 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/Science, Computer Science, Information Technology or related field.

+ 5+ years in pharmaceutical manufacturing, with specific experiences to computer system validation, and data integrity principles.

+ 2+ years of direct people leadership.

** Additional Skills/Preferences:*
* + Previous facility or area start up experience

+ Previous experience in QA, QC Science/Engineering or Computer Science and Technology

+ Prior work with cGMPs, external regulations and inspections

+ 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.

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