Associate Director Data and Systems QA
Eli Lilly and Company
5 hours ago
On-site
Lebanon, IN
IT
Job Position Overview
The Quality Assurance Associate Director of Data and Systems QA develops and maintains quality and regulatory compliance for computer systems at LP1, provides Data Management oversight and governance, and serves as the Site Data Leader. Manages direct reports and prioritizes work to implement LP1, Computer System Quality Assurance (CSQA), and Data Management objectives.
Responsibilities
- Provide direct quality oversight to LP1 computer system validation (CSQA); assist with interpretation of regulatory and corporate requirements related to CSQA and data integrity/management.
- Provide quality guidance, technical support, and recommendations for CSV and data integrity principles, process issues, and continuous improvement initiatives.
- Serve 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 on 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 experience in computer system validation and data integrity principles.
- 2+ years of direct people leadership.
Additional Skills/Preferences
- Prior facility or area start-up experience.
- Experience in QA, QC Science/Engineering, or Computer Science/Technology.
- Experience 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.
- Strong technical aptitude; ability to train and mentor others.
Schedule
- Monday–Friday, 8 hours/day; additional support may be required for critical situations.
The Quality Assurance Associate Director of Data and Systems QA develops and maintains quality and regulatory compliance for computer systems at LP1, provides Data Management oversight and governance, and serves as the Site Data Leader. Manages direct reports and prioritizes work to implement LP1, Computer System Quality Assurance (CSQA), and Data Management objectives.
Responsibilities
- Provide direct quality oversight to LP1 computer system validation (CSQA); assist with interpretation of regulatory and corporate requirements related to CSQA and data integrity/management.
- Provide quality guidance, technical support, and recommendations for CSV and data integrity principles, process issues, and continuous improvement initiatives.
- Serve 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 on 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 experience in computer system validation and data integrity principles.
- 2+ years of direct people leadership.
Additional Skills/Preferences
- Prior facility or area start-up experience.
- Experience in QA, QC Science/Engineering, or Computer Science/Technology.
- Experience 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.
- Strong technical aptitude; ability to train and mentor others.
Schedule
- Monday–Friday, 8 hours/day; additional support may be required for critical situations.