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Job Title: Principal Associate Computer Systems Quality Assurance (CSQA) for E-Systems
Location: Limerick, Ireland
Company: Eli Lilly & Company
About Us: Eli Lilly Limerick is a cutting-edge biotechnology company dedicated to revolutionizing the healthcare industry through the development and production of next-generation biopharmaceuticals. Our state-of-the-art manufacturing facility is at the forefront of innovation, employing the latest bioprocessing technologies to create life-saving therapies. We are seeking a highly motivated and detail-oriented CSQA Principal Associate to join our quality assurance team and ensure the highest standards of product quality and compliance for our electronic systems.
Position Summary: As a CSQA Principal Associate, you will play a critical role in developing, designing, maintaining the quality and regulatory compliance of our biopharmaceutical products within our next-generation manufacturing facility. You will be a foundational member of a greenfield site, responsible for shaping quality processes and ensuring that digital solutions and laboratory instrumentation are qualified, maintained, and operated in compliance with global regulatory requirements (FDA, EU, ICH, ISO, GAMP 5). This is a hands-on and strategic role at the intersection of quality, digitalization, and laboratory operations — ideal for someone who thrives in dynamic, startup-like environments. You will work closely with cross-functional teams to implement and develop, design, uphold quality assurance standards, facilitate inspections and audits, and support continuous improvement initiatives.
Key Responsibilities:
1. Quality Assurance Design and Oversight:
- Implement Global Quality Standards to the new Lilly Limerick site.
- Provide quality direction and governance for QA-owned e-systems, site IT systems, and site laboratory systems.
- Develop and maintain quality assurance procedures, policies, and systems.
- Conduct routine self-inspections and monitoring assessments (time-on-the-floor) to ensure compliance with cGMP (current Good Manufacturing Practices) and other relevant regulations.
- Investigate and address deviations, non-conformities, and CAPA (Corrective and Preventive Actions) to maintain quality.
- Review and approve change controls related to GxP systems and lab equipment, ensuring appropriate impact and risk assessments.
- Apply ICH Q9 principles to qualify and mitigate risks in system-related changes or deviations Participate in IT and quality organizations to provide consistency across all computer systems areas.
- Evaluate events related to data loss, system outages, or unauthorized access from a quality and compliance perspective.
- Perform and support data flow mapping for production, analytical, and site-wide processes.
- Partner with Digital/IT, QC, TSMS and Engineering teams to ensure GxP compliance of all laboratory e-systems and analytical technologies.
- Ensure compliance with CSV and data integrity principles, including ALCOA+ and 21 CFR Part 11.
2. Regulatory Compliance:
- Stay current with industry regulations, guidelines, and best practices.
- Assist in the preparation and execution of regulatory inspections and audits.
- Ensure compliance with periodic review, change control, deviation, back up and archive, security, and other support processes for IT systems.
- Participate in quality meetings keeping the group updated on initiatives within the QA owned GMP IT systems.
- Conduct or oversee data integrity assessments across systems and equipment and contribute to audit readiness for QA owned systems, QC systems and Process analytical technology systems.
- Assess compliance with 21 CFR Part 11 / EU Annex 11 for electronic records, electronic signatures, audit trails, user access, and backup/restore functions.
- Review audit trail reviews, non-terminal record reviews, exception reports, and integrity control mechanisms.
- Ensure GxP computerized systems undergo routine periodic reviews to assess validation status, user access, audit trail review, and backup testing.
- Ensure readiness of computerized systems and equipment documentation and provide defense of QA oversight activities.
- Support CSV (Computerized System Validation) strategy and execution for GxP systems, ensuring fitness for intended use and regulatory compliance
3. Documentation and Reporting:
- Maintain accurate and comprehensive quality records, change control documentation, and quality reports.
- Develop common local procedures for computer systems and help the site consistently interpret and implement global policies across all computer systems areas.
- Develop or contribute to GxP procedures, templates, and guidance documents related to CSV, equipment qualification, data integrity, and system governance.
- Review and approval of key GMP documents such as GMP standard operating procedures and CSV deliverables as appropriate to area of responsibility.
- Review and approval of GMP documents associated with qualification and validation including IQ/OQ/PQ & validation documents for facilities, equipment, computer systems, GMP utilities and system periodic review reports as appropriate to area of responsibility.
4. Quality Improvement Initiatives:
- Identify areas for process improvement and work collaboratively with cross-functional process teams to implement changes.
- Participate in risk assessments and quality improvement projects.
- Drive risk-based decision-making and QA input into digital and automation initiatives.
- Identify and implement QA best practices in support of a fully digital lab environment.
- Provide independent QA oversight throughout the computerized system lifecycle: from planning, specification, qualification/validation, operation, to retirement/decommissioning
5. Training and Development:
- Provide training to staff on all relevant aspects of computer system quality.
- Stay informed about the latest developments in computer systems validation and quality assurance.
- Deliver training on CSV principles, data integrity, and regulatory expectations to internal teams.
- Promote a culture of compliance and continuous improvement related to computerized systems and lab automation.
Qualifications:
- BSc, Hons BSc, MSc, or PhD in Science, Engineering, Quality, or related discipline.
- Minimum of 5 years of experience in quality assurance within a biotechnology, pharmaceutical, or medical device manufacturing environment.
- Strong knowledge of cGMP, FDA, Data Integrity, Quality Risk Management and other biopharmaceutical regulatory requirements.
- Excellent problem-solving and analytical skills.
- Detail-oriented with a strong commitment to maintaining high-quality standards.
- Effective communication and teamwork skills.
- Demonstrated initiative – able to work proactively without direct supervision and with a continuous improvement mind-set.
- Experience with data flow mapping and within electronic quality management systems (e.g., TrackWise) and other pharmaceutical IT systems.
- Experience in computerized system validation of QC equipment and process analytical technology.
- Self-driven and comfortable working independently in a dynamic, startup-like environment.
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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