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 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.

At Lilly in Germany, we are currently planning and building a high-tech production facility in Alzey (Rhineland-Palatinate), which will expand our production of injectable drugs from 2027 and employ up to 1,000 specialists. To make the most of our innovative production site, we are looking for motivated reinforcements who, together with us, will ensure the supply of Lilly medicines in Germany, Europe, and worldwide, in line with the three Lilly values of "Excellence," "Integrity," and "Respect for People."

Responsibilities:

As Sr. Manager - Computer System Validation and Data Integrity, your will partner with the Site Data Leader and Site Tech@Lilly leadership to implement the computer system validation (CSV) and Data integrity strategies and culture for Site Tech@Lilly.  This role will leverage a deep understanding of CSV and Data Integrity principles ensuring compliance with regulatory requirements, consistent application, and sustainability for local and global Tech@Lilly systems used at the Alzey site. This role will collaborate with the local and global CSQA and Tech@Lilly organizations to enable best practices, processes, and governance and to consider new points to strengthen the Tech@Lilly CSV and Data Integrity position and align with corporate objectives and initiatives.

Key Objectives/Deliverables:

• This role will be responsible for the implementation of the Data Integrity culture and CSV & DATA INTEGRITY strategies for site Tech@Lilly ensuring compliance with global and local regulatory requirements for systems used at the site (both local and global).
• Coordinate the technical evaluation with site Tech@Lilly subject matter experts (SMEs) of new and existing systems from a Data Integrity and CSV perspective.
• Provide CSV & DATA INTEGRITY consulting and assist with articulation of CSV & DATA INTEGRITY needs to the CSV & DATA INTEGRITY third party service provider(s).
• Lead the implementation of technology solutions across the site to improve CSV & DATA INTEGRITY compliance.
• Collaborate internally and externally to establish best practices and evaluate new points of consideration to improve technology use at the site.
• Partner with the Site Data Leader and Tech@Lilly leadership to lead the gap analysis and remediation efforts of policies associated with LQPs, GQS, SOPs and CSV & DATA INTEGRITY.
• Represent site Tech@Lilly in CSV & DATA INTEGRITY related deviations and CAPAs.
• Provide support in the event of internal, external, and regulatory audits.
• Partner cross-functionally with site DI SMEs to ensure a common, systematic approach to meeting existing and new CSV & DATA INTEGRITY expectations. This includes, but is not limited to, audit trail management, workstation security, and connecting stand-alone equipment.
• Solves problems while exhibiting judgment.
• Ensures Lilly information assets are protected from malicious content and access to information is restricted to authorized personnel only.

Basic Qualifications:

• Bachelor’s degree in Software Engineering, Computer Science, Computer Engineering, or a related field.
• Experience working in a regulated industry (i.e., GMP) and strong understanding of quality processes in IT applying to manufacturing and distribution.
• Proficiency with CSV & DATA INTEGRITY and demonstrated ability to right-size validation based upon risk.
• Solid knowledge of Computer System Validation process and Data Integrity.
• Excellent communication and interpersonal skills to build relationships with stakeholders and articulate complex technical concepts.
• Strong analytical and problem-solving skills to identify and resolve technical issues related to Labs systems, configurations, or integrations. Demonstrated ability to analyze, anticipate, and resolve complex issues (technical, operational, or business-related). Effectively prioritize and escalate issues.
• Adaptability and flexibility to work in a fast-paced environment and manage multiple tasks simultaneously.

Additional Skills/Preferences:

• Master’s degree in Software Engineering, Computer Science, Computer Engineering, or a related field.
• Understanding of cybersecurity concepts and best practices related to IT technologies.
• Build solutions using an agile framework for the entire solution lifecycle including designing, implementing, automating, modernizing, maintaining, and optimizing solutions.
• Experience with technical mentoring and developing technical team members.
• Exposure to international operations, diverse teams, global IT projects, or working in a global organization.
• Proficiency in German and strong English language skills
• On-site presence required 

What can you look forward to with us?

• Pioneering spirit: Become part of a team of specialized professionals that will grow to up to 1,000 colleagues over the next three years.
• Innovation: You will work in a medical high-tech production facility equipped with the most advanced technology.
• Creative freedom: From the beginning, you will have the freedom to contribute your ideas and implement them in cross-functional teams.
• Development: We value the individual career development of our employees and ensure fair access to professional development worldwide through our "Lilly University."
• Financial benefits: In addition to your attractive salary, we offer you the option of an excellent company pension plan and other individual benefits.

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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