CSV Common Process Lead – GISQ

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Position Description:

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.

Key Objectives/Deliverables:

CSV Lifecycle Process Oversight

- Change Management: Provide SME guidance and oversight for GxP change control of computerized systems, including impact assessment, risk-based testing and validation scope, and release/implementation, ensuring changes (including supplier-initiated releases, in partnership with the CSV External Services Lead) are assessed for impact to the validated state. Provides alignment between IT and QMS Change Management processes.
- Deviation and CAPA Management: Provide SME guidance and oversight for computerized system deviations and CAPAs, including event classification, impact assessment, root cause analysis, CAPA effectiveness, and timely closure; partner with the Deviation Review Board to drive record quality and timeliness.
- Periodic Review: Own and maintain the periodic review process, ensuring reviews are risk-based, scheduled and completed on time, and conclude with a documented determination of continued validated state and actions to address gaps.
- Retirement/Decommissioning: Provide guidance and oversight for system retirement and decommissioning, including data migration verification, archival, record retention, and continued accessibility and readability of GxP records for the required retention period.
- Procedural Updates: Author, revise, and maintain controlled procedures, templates, and job aids for the CSV common processes; conduct periodic procedure reviews and ensure training impact is assessed and communicated for every change.
- Regulatory Alignment: Lead regulatory intelligence and gap assessments for the CSV common processes (e.g., proposed revisions to EU GMP Annex 11, FDA Computer Software Assurance, data integrity and AI-related guidance), translating new or revised requirements into procedural updates and implementation plans.
- Related Operational Controls: Provide SME support for other operational-phase controls that protect the validated state, such as configuration management, incident and problem management, access management, backup and restore, business continuity/disaster recovery, and audit trail review.

Maintain Inspectional Readiness

- Set and defend the Lilly position on CSV lifecycle practices, leading preparation of process narratives and SME support for health authority inspections and audits, and drafting or reviewing responses to related observations.
- Ensure all quality actions and commitments for the CSV common processes, including inspection and audit commitments, are appropriately tracked in Quality/CAPA plans and completed on time.
- Provide periodic updates to GISQ leadership and key stakeholders on process health, emerging risks, and the status of commitments.

Deliver Projects, Programs, and Support

- Provide consultation/interpretation on computer system LQS/LQPs governing lifecycle processes, while appropriately escalating computer system quality issues.
- Be a GISQ/Tech@Lilly process owner (e.g., LQP or LCS) for assigned CSV common processes.
- Support GISQ management (M2/M3/M4) in overseeing strategic/complex process changes, providing a clear message and direction to the functional AVP/IOs.
- As part of ‘account management’, create and maintain periodic touchpoints with CSQA representatives and functional areas to discuss trends, impact of upcoming Quality implementations, potential improvements, and areas of concern.
- Strive for and promote consistency within the GISQ organization.
- Develop and deliver training on CSV lifecycle processes to GISQ colleagues and business partners, as needed.

Streamline and Continuously Improve

- Eliminate non-value-added activities within the CSV common processes, applying risk-based approaches (e.g., GAMP 5 Second Edition, Computer Software Assurance principles) to right-size effort. This may include engagement in Six Sigma projects and other process improvement activities.
- Identify opportunities to streamline, simplify, and harmonize lifecycle processes across GxP domains, driving the development of improved solutions.
- Use performance data and trends to focus improvement where it will most reduce compliance risk.
- Understand external trends and potential ramifications for the CSV common processes and supported IT area(s).

Grow Capabilities and Knowledge

- Become the recognized regulatory authority/expert for computerized system lifecycle processes within GISQ and Tech@Lilly.
- Liaise and develop networks with other Quality organizations (e.g., site Quality, enterprise QMS process owners).
- Be proactive in benchmarking processes both internal and external to Lilly (e.g., ISPE GAMP communities of practice).

Minimum Requirements:

·       Bachelor degree in a science, engineering, computer science/systems, or pharmaceutical-related field; or equivalent experience.

·       5+ years of demonstrated expertise in Computer System Validation and computerized system lifecycle management, with strong working knowledge of GAMP 5, 21 CFR Part 11, EU GMP Annex 11, data integrity guidance, and related global regulatory expectations.

·       5+ years of demonstrated expertise with GxP QMS processes for computerized systems (e.g., change control, deviation/CAPA, periodic review, retirement/decommissioning), including authoring or owning controlled procedures.

·       Prior role experience holding delegated quality authority: interpreting requirements, approving exceptions, and accepting or escalating risk.

·       Prior role experience supporting or leading health authority inspections and audits, including drafting and defending the company position on CSV practices.

·       Demonstrated ability to contribute and influence at the Executive Leadership level.

·       Strong analytical and problem-solving abilities, including the ability to interpret systemic performance trends and direct corrective action.

·       Demonstrated strong oral and written communication, interpersonal interaction skills, and ability to influence and collaborate.

·       Proficiency with IT systems development life cycle and demonstrated ability to right-size validation based upon risk.

·       Ability to focus across multiple processes (end-to-end viewpoint).

Additional Preferences:

·       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).

Other Information:

·       This is an individual contributor role with no direct people-management responsibility.

·       Must complete Lilly’s CSQA Qualification Program.

·       The position is based in Indianapolis, Indiana, and may require occasional travel.

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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is
$117,000 - $171,600

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Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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