Sr. Manager - Computer System Validation and Data Integrity

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 work to discover and bring life-changing medicines to those in need, improve disease management, and give back to communities through philanthropy and volunteerism. We prioritize putting people first and are seeking dedicated individuals who share our mission.

In Germany, we are building a high-tech production facility in Alzey (Rhineland-Palatinate) to expand our injectable drug production from 2027, employing up to 1,000 specialists. We are looking for motivated professionals to ensure the supply of Lilly medicines across Germany, Europe, and globally, aligned with our core values of "Excellence," "Integrity," and "Respect for People."

Responsibilities:

As Sr. Manager - Computer System Validation and Data Integrity, you will partner with the Site Data Leader and Site Tech@Lilly leadership to implement and uphold CSV and Data Integrity strategies at the Alzey site. Your role involves ensuring compliance with regulatory standards, collaborating with global and local teams, and driving best practices to strengthen our data integrity and validation processes.

Key Objectives/Deliverables:

• Implement Data Integrity culture and CSV strategies, ensuring regulatory compliance.
• Evaluate new and existing systems for Data Integrity and CSV compliance with site SMEs.
• Consult on CSV and Data Integrity needs with third-party providers.
• Lead technology solutions to enhance compliance.
• Establish best practices and evaluate new technology use at the site.
• Lead gap analysis and remediation of policies related to LQPs, GQS, SOPs, and CSV/Data Integrity.
• Represent the site in CSV and Data Integrity deviations and CAPAs.
• Support internal, external, and regulatory audits.
• Ensure systematic approach to CSV and Data Integrity, including audit trail management and workstation security.
• Protect Lilly's information assets from malicious threats.

Basic Qualifications:

• Bachelor’s degree in Software Engineering, Computer Science, or related field.
• Experience in regulated industries (GMP) with strong IT quality process knowledge.
• Proficiency in CSV & Data Integrity, with ability to tailor validation efforts based on risk.
• Knowledge of Computer System Validation and Data Integrity principles.
• Excellent communication skills for stakeholder engagement and technical articulation.
• Strong analytical and problem-solving skills, with ability to prioritize and escalate issues effectively.
• Adaptability to a fast-paced, multi-task environment.

Additional Skills/Preferences:

• Master’s degree in relevant fields.
• Understanding of cybersecurity best practices.
• Experience with agile development frameworks.
• Mentoring experience and international project exposure.
• Proficiency in German and strong English skills.
• On-site presence required.

What We Offer:

• Join a pioneering team growing to 1,000+ professionals.
• Work in a state-of-the-art medical high-tech facility.
• Contribute ideas and see them implemented in cross-functional teams.
• Access professional development through Lilly University.
• Competitive salary, pension plan, and additional benefits.

Lilly is committed to diversity and inclusion. If you need accommodations during the application process, please complete our Workplace Accommodation Request Form. We do not discriminate based on age, race, gender, or other protected statuses.