Associate Director - Computer Systems & Data Management

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.

The Associate Director - Computer Systems and Data Management will report directly to the Executive Quality Director and will also serve as Site Data Leader for Sesto. This position offers a fantastic opportunity to provide pivotal support across the organization for significant quality projects and initiatives. You’ll work closely with manufacturing teams, Tech@Lilly, and cross-functional collaborators to assess processes and ensure alignment with LQS/LQP and Global Lilly SOPs. Your leadership will make a meaningful impact on our efforts in Data Management, setting the stage for excellence and innovation.

MAIN RESPONSIBILITIES

Local Role:

• Guarantees Quality oversight of the activities related to System Validation, ensuring the application of GMPs and compliance with the Global Quality Standards (GQS)
• Led the CSQA team, participated in governance meetings related to system validation activities, and supported the system validation strategy for projects at the site.
• Coordinate the Data Management Lead Team, actively participate in the Quality Lead Team, and Quality governance (DRB, CRB, Quality staff, etc.).
• Propose, support, or approve strategic decisions related to the site's approach to system qualification/validation and Data Management/Data Integrity, and influence the network to drive consistency and alignment.
• Serve as liaison between the global organization and other sites and any cross-site/global initiatives related to QA CSQA, and Data Management.
• Collaborate with the GMP compliance team on the inspection readiness program, self-inspection activities, and external audits.
• Approve significant change control activities and deviations related to system validation and Data Management.
• Ensure, through the team, quality oversight, coordination, or management of initiatives/projects/capital projects coming from the technical team, the secondary loop, and the Quality organization.

Site Data Leader:

• Own site actions associated with enterprise data management and integrity initiatives.
• Facilitate the Site Data Lead Team.
• Maintain site data management metrics and track the status of the data integrity action plans; report the status to the Site Data Lead Team.
• Provide directions on the operationalization of the data management action plan.
• Partner with site leadership to ensure data integrity initiatives are given appropriate priority and resources.
• Partner with functional site data subject matter experts (SMEs) to ensure that data management actions are completed according to the established plan.
• Own the responsibility for enhancing and sustaining data management and integrity principles throughout the data lifecycle.

REQUIRED QUALIFICATIONS

• Master’s Degree in PharmD, Engineering, Chemical, Biotech, or related fields.
• Fluent in English.
• 10/15 years in the pharmaceutical industry, with demonstrated experience in CSQA, IT, Quality, and Project Management.
• Knowledge of CSQA, GMPs, Parenteral processes, Data Integrity.
• Good know-how on lab and manufacturing systems.

• Teamwork, problem-solving, and decision-making skills.
• Technical leadership.
• Organizational and technical teams' managerial capabilities.

This position requires working on-site, and includes 4 days of remote work per month.

What we offer:

Step into a role where your expertise is recognized, appreciated, and rewarded. As a member of our team, you can expect:

• Competitive Salary: We offer a competitive base salary supplemented by an annual variable component based on achieving objectives.
• Relocation Package: You will be eligible for a relocation package based on your location.
• Comprehensive Benefits: Enjoy a well-rounded welfare package, including an extensive insurance plan.
• Annual Salary Review: We recognize and reward your continued effort with an annual salary review, providing opportunities for advancement based on your performance. As part of our commitment to your future, you may also be eligible to receive a stock option package, aligning your success with the company's growth.

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 (https://careers.lilly.com/us/en/workplace-accommodation) 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 does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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