Associate Director Data and Systems QA

Eli Lilly and Company • Lebanon, IN

12d • $123,000 - $180,400 • Onsite

About The Position

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.

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.

Nice To Haves

• 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

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.

Benefits

• company bonus
• company-sponsored 401(k)
• pension
• vacation benefits
• medical benefits
• dental benefits
• vision benefits
• prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance
• death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Manager