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Job Description

Job title: Associate Director, IT CSV and Compliance

Reporting To: Senior IT Director, MQ Limerick

Location: On-site in Raheen, Limerick

Lilly is currently constructing a Next Generation Biotech Drug Substance Manufacturing Facility in Raheen, Limerick, Ireland. This facility will be Lilly’s most technically advanced manufacturing site and will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and increased productivity and process performance.

Main Purpose and Objectives of Position:

We are seeking an experienced and detail-oriented Manager – CSV & Compliance to lead and oversee the validation and compliance of computerized systems within our Limerick Site. This role ensures that all GxP-regulated systems meet applicable regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11) and internal quality standards. The ideal candidate will bring deep expertise in CSV, a strong understanding of regulatory frameworks, and proven leadership in managing cross-functional teams and projects.

Key Duties and Responsibilities:

• Lead the planning, execution, and documentation of Computer System Validation (CSV) activities across GxP systems.
• Ensure compliance with FDA, EMA, MHRA, and other global regulatory requirements related to computerized systems.
• Develop and maintain validation master plans, risk assessments, protocols (IQ/OQ/PQ), and reports.
• Collaborate with IT, QA, manufacturing, and laboratory teams to ensure systems are validated and maintained in a compliant state.
• Manage audits and inspections related to CSV and data integrity; serve as SME during regulatory inspections.
• Drive continuous improvement in validation processes, leveraging industry best practices and emerging technologies (e.g., CSA, cloud-based systems).
• Oversee the implementation and maintenance of data integrity and compliance frameworks.
• Provide training and mentorship to team members and stakeholders on CSV and compliance topics.
• Maintain a strong understanding of evolving regulatory expectations and industry trends.

Requirements:

• Bachelor’s or Master’s degree in Life Sciences, Computer Science, Engineering, or related field.
• Minimum 7+ years of experience in CSV, compliance, or QA roles within the pharmaceutical, biotech, or medical device industry.
• In-depth knowledge of GAMP 5, 21 CFR Part 11, Annex 11, ICH Q9/Q10, and data integrity principles.
• Experience with ERP, LIMS, MES, QMS, and cloud-based systems in a regulated environment.
• Excellent communication, documentation, and stakeholder engagement skills.
• Strong project management and leadership skills.

Preferred Skills:

• Familiarity with Computer Software Assurance (CSA) principles.
• Experience with AI/ML systems validation or digital transformation initiatives in regulated environments.
• Prior involvement in regulatory inspections (FDA, EMA, etc.).
• Knowledge of 21st-century validation approaches (e.g., risk-based validation, agile methodologies).

Come join our team

• Be Creative, Be an Innovator, and most of all, Be Yourself!

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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