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 worldwide work to discover and bring life-changing medicines to those in need, improve understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We prioritize putting people first and strive for excellence in our work.

In Germany, we are planning and building a high-tech production facility in Alzey (Rhineland-Palatinate), which will expand our production of injectable drugs from 2027, employing up to 1,000 specialists. We seek motivated professionals to join us in ensuring 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 promote CSV and Data Integrity strategies and culture at the Alzey site. Your role will leverage deep knowledge of CSV and Data Integrity principles to ensure compliance with regulatory requirements, consistent application, and sustainability across local and global Tech@Lilly systems. Collaboration with local and global CSQA and Tech@Lilly teams will be essential to establish best practices, processes, governance, and to enhance the CSV and Data Integrity framework in line with corporate objectives.

Key Objectives/Deliverables:

• Implement Data Integrity culture and CSV & Data Integrity strategies, ensuring compliance with regulatory standards.
• Coordinate technical evaluations of new and existing systems from a Data Integrity and CSV perspective with site SMEs.
• Provide consulting on CSV & Data Integrity needs and liaise with third-party service providers.
• Lead technology solutions implementation to improve compliance.
• Establish best practices and evaluate new considerations for technology use.
• Lead gap analysis and remediation efforts related to policies, SOPs, and standards.
• Represent the site in CSV & Data Integrity deviations and CAPAs.
• Support internal, external, and regulatory audits.
• Partner cross-functionally to ensure systematic approaches to CSV & Data Integrity, including audit trail management and workstation security.
• Ensure information assets are protected and access is restricted appropriately.

Basic Qualifications:

• Bachelor’s degree in Software Engineering, Computer Science, or related field.
• Experience in regulated industries (GMP preferred) with a strong understanding of quality IT processes.
• Proficiency in CSV & Data Integrity, with ability to adapt validation based on risk.
• Knowledge of Computer System Validation and Data Integrity principles.
• Excellent communication and interpersonal skills.
• Strong analytical and problem-solving abilities, with experience in resolving complex technical issues.
• Ability to adapt and manage multiple tasks in a fast-paced environment.

Additional Skills/Preferences:

• Master’s degree in relevant fields.
• Understanding of cybersecurity best practices.
• Experience with agile development and solution lifecycle management.
• Mentoring experience and exposure to international operations or global IT projects.
• Proficiency in German and strong English skills.
• On-site presence required.

What can you look forward to with us?

• Pioneering spirit: Join a growing team of up to 1,000 professionals.
• Innovation: Work in a state-of-the-art medical high-tech production facility.
• Creative freedom: Contribute ideas and implement them in cross-functional teams.
• Development: Access professional growth opportunities through Lilly University.
• Financial benefits: Competitive salary, pension plan, and other benefits.

Lilly is committed to accommodating individuals with disabilities in the application process. For assistance, please complete our workplace accommodation request form. We do not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, national origin, veteran status, disability, or other protected categories.

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