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.
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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