Computer Systems Quality Process Lead

The CSV Common Process Lead is an individual-contributor Quality technical lead role within the Global Information Systems Quality (GISQ) organization. The role serves as the enterprise subject matter expert (SME), advisor, and quality oversight lead for the GxP computerized system lifecycle processes and Quality Management System (QMS) elements that establish and maintain the validated state of Lilly’s regulated computerized systems, and is responsible for:

• Providing deep SME and advisory support for the computerized system lifecycle processes that sustain the validated state, including but not limited to change management, deviation and CAPA management, periodic review, and retirement/decommissioning, across GxP disciplines (GMP, GCP, GLP, GVP)

• Serving as process owner or designated SME for the CSV common processes and their controlled procedures within applicable policies and standards, ensuring the process architecture is coherent, consistent, and fit for purpose across all systems and business areas.

• Seeking and interpreting external information sources (e.g., FDA, EMA, MHRA, PIC/S, ICH, ISPE GAMP) and leading impact assessments and procedural updates so the CSV common processes remain aligned with evolving regulatory expectations.

• Providing quality oversight of lifecycle process execution, reviewing process health and systemic performance trends (e.g., timeliness, extensions, aging, recurrence, record quality), and directing corrective and preventive action when trends signal systemic issues.

• Interpreting CSV-related regulatory and quality requirements, approving exceptions, and accepting or escalating risk within delegated authority, acting as the definitive quality voice for the CSV common processes.

• Representing the CSV common processes during health authority inspections, internal audits, and self-inspections, including setting and defending Lilly’s position on computerized system lifecycle practices.

• Serving as the primary point of alignment for the CSV common processes between Tech@Lilly, business partners, Quality, and supporting functions, ensuring process direction reflects and informs their needs.

·       Prior experience with Lilly Quality Systems (deviations, analytical investigations, change, and/or complaints) and enterprise QMS platforms (e.g., Veeva QMS).

·       Global experience working across regions and multiple GxP domains (GMP, GCP, GLP, GVP).

·       Understanding of process development and/or improvement (e.g., Six Sigma, Lean).

·       Experience with data analytics and business intelligence tools (e.g., Power BI) to support performance governance and process reporting.

·       Familiarity with risk-based assurance approaches (e.g., FDA Computer Software Assurance, ICH Q9(R1)) and validation of agile/continuous delivery models.

·       Broad IT technical competency, to include emerging technologies (e.g., Cloud, Machine Learning, Artificial Intelligence, etc.).

·       Ability to relate system use to potential impact to products and patients.

·       Knowledge of IT Best Practices (e.g., LSEF, ITIL).

·       A track record of driving innovation and implementing creative solutions to improve CSV process efficiency and effectiveness.

·       Membership and active participation in external forums/organizations (e.g., ISPE GAMP).