Associate Director - Computer System Quality Assurance & Site Data Lead

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.

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 looking for a highly motivated and detail-oriented CSQA Associate Director to join our quality assurance team. The selected candidate will be responsible for ensuring the highest standards of product quality and compliance for our electronic systems and data integrity requirements.

The Associate Director – Computer Systems Quality Assurance & Data Integrity will play a critical role in developing, designing, maintaining the quality and regulatory compliance of our biopharmaceutical products within our next-generation manufacturing facility. The individual will be responsible for ensuring the quality, integrity, and compliance of GxP computerized systems, including manufacturing, warehouse and laboratory systems. The role focuses on implementing robust data governance practices, executing computer system validation (CSV), supporting laboratory informatics systems (e.g., LIMS, CDS, ELN), warehouse and manufacturing systems (MES, DeltaV, etc.), and driving compliance with global regulatory expectations. This leadership position will work closely with cross-functional teams and supports inspections, continuous improvement, and quality culture development at the site and global level.

Key Responsibilities:

Quality Systems and Data Integrity:

• Implement Global CS and DI Quality Standards to the new Lilly Limerick site.
• Provide quality direction and governance for QA-owned e-systems, site IT systems, manufacturing systems and site laboratory systems.
• Develop and maintain quality assurance procedures, policies, and systems related to data management, and CSV.
• Conduct routine self-inspections and monitoring assessments (time-on-the-floor) to ensure compliance with cGMP (current Good Manufacturing Practices), Data Integrity and other relevant regulations.
• Participate in IT and quality organizations to provide consistency across all computer systems areas.
• Perform and support data flow mapping for production, analytical, and site-wide processes.
• Ensure accurate documentation of quality records, validation activities, and system-related compliance data.
• Oversee system change control, deviation management, CAPA, and system periodic review processes.
• Investigate and address deviations, non-conformities, and CAPA (Corrective and Preventive Actions) to maintain quality.
• Develop and implement comprehensive data governance frameworks to ensure data quality, consistency, and integrity throughout its lifecycle.
• Lead data mapping and flow assessments across lab, manufacturing, and support functions.
• Collaborate with data owners and functional teams to establish and monitor data integrity KPIs.
• Perform risk assessments and inspections to identify and mitigate data integrity vulnerabilities.
• Provide QA oversight for manufacturing (MES, DeltaV, DCS), laboratory (LIMS, ELN, and benchtop instruments) and logistics systems (SAP, EWM etc.).
• Ensure systems are qualified, validated, and remain in a compliant state per regulatory expectations.
• Support automation initiatives and integration with enterprise systems.
• Review and approve system validation documents, including URS, IQ/OQ/PQ, periodic reviews, and change controls.

Computer System Validation (CSV):

• Ensure all GxP computerized systems meet CSV requirements and are aligned with global standards (e.g., 21 CFR Part 11, Annex 11, GAMP 5).
• Oversee validation lifecycle from planning through retirement, ensuring traceability and compliance.
• Provide QA review and approval for CSV deliverables, deviations, and risk-based validation strategies.

Regulatory Compliance & Inspection Readiness:

Act as a site data lead, serve as Quality SME for data integrity and systems during internal and external inspections.
• Maintain inspection readiness across all supported systems, ensuring alignment with corporate and regulatory standards.
• Stay current with industry regulations, guidelines, and best practices.
• Interpret evolving regulations and ensure site policies and procedures are kept current and aligned.
• 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.

Continuous Improvement & Strategy:

• Identify areas for optimization in data flow, system integration, and validation strategies.
• Champion initiatives in digital transformation, data contextualization, and visualization to enhance decision-making and compliance.
• Align site and global system strategies and contribute to data governance networks.

Training & Leadership:

• Deliver training on data integrity principles, laboratory and computer system compliance, and validation methodologies.
• Mentor team members and functional stakeholders to build local capability in data management and CSV.
• Support talent development and promote a strong compliance culture.

Education:

• Bachelor’s or advanced degree in Science, Engineering, Computer Science, Quality or a related discipline.
• Advanced degrees (e.g., MSc, PhD) are desirable.

Experience:

• 10+ years with leadership in quality, compliance, data governance, and lab systems validation and quality assurance.

Required Skills:

• Strong working knowledge of FDA, EMA, HPRA, MHRA, and other regulatory authorities for data integrity, CSV, Quality Risk Management (QRM) and biopharmaceutical regulatory requirements.
• Deep understanding of lab systems such as LIMS, CDS, ELN, and instrument software validation.
• Proficiency with validation frameworks (e.g., GAMP 5), risk management, and audit readiness.
• Experience with enterprise systems (e.g., TrackWise, Veeva, SAP), digital platforms, and automation environments (e.g., MES, DeltaV, DCS).
• Exceptional communication, cross-functional leadership, and decision-making abilities.

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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