CSV Supplier Oversight Lead

BioSpace; Indianapolis (IN); Sur place; USD 117 000 - 172 000; Plein temps

Avantages offerts par ce poste

Comprehensive benefits

Résumé du poste

Lilly seeks a CSV External Services Lead within GISQ to provide quality leadership for suppliers and third parties that develop or host GxP computerized systems. This individual-contributor role owns risk-based supplier assessments, manages observations and CAPAs, and ensures QTAs and SLAs reflect proper GxP responsibilities.

Travel is required to support supplier audits, and the position is based in Indianapolis, Indiana.

Qualifications

• Bachelor-level degree or higher in a science, engineering, computer science, or pharmaceutical-related field.
• Experience with Computer System Validation (CSV) and GxP regulatory expectations.
• Experience planning, leading, and reporting assessments of computerized system suppliers or IT service providers.
• Experience authoring/negotiating Quality Technical Agreements and defining SLA requirements.
• Experience managing supplier or managed-service relationships without direct people-management responsibility.

Responsabilités

• Lead risk-based quality management of computerized system suppliers and third-party providers across service models.
• Own supplier assessments from planning through execution and requalification.
• Manage audit observations and CAPAs; escalate when commitments are not met.
• Define QTAs and SLAs reflecting GxP responsibilities; collaborate with Procurement and Legal.
• Monitor supplier performance against QTAs/SLAs and drive corrective actions.
• Interpret regulatory expectations (EU GMP, 21 CFR Part 11, ICH) for outsourced activities.
• Represent supplier oversight during inspections and audits with accountability for GxP activities.
• Collaborate with cross-functional teams to integrate quality requirements into the full supplier lifecycle.
• Provide regular updates on supplier risk, audit status, and emerging risks.
• Be a process owner for supplier management procedures and mentor others.

Connaissances

Quality oversight

Risk assessment

GxP compliance

Vendor management

Audit management

Formation

Bachelor degree in science/engineering/computer science or pharmaceutical-related field

Description du poste

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 External Services 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) and quality oversight lead for the suppliers and third parties that develop, host, operate, support, or validate Lilly’s GxP computerized systems, and is responsible for:

Leading risk-based quality management of computerized system suppliers and third-party service providers across all service models, including commercial off-the-shelf (COTS) software, configured and custom development, Software-as-a-Service (SaaS), Platform-/Infrastructure-as-a-Service (PaaS/IaaS) and cloud hosting, managed IT services, and outsourced CSV/managed-service providers.

Owning the computerized system supplier assessment, from risk-based planning and scheduling through assessment execution, reporting, and requalification.

Managing audit observations and reports through supplier response, CAPA, verification of effectiveness, and closure, escalating when commitments are not met or residual risk is unacceptable.

Defining and approving the quality requirements in Quality Technical Agreements (QTAs) and the quality-relevant terms of Service Level Agreements (SLAs), partnering with Procurement, Legal, and service owners so that GxP responsibilities are clearly allocated and enforceable.

Monitoring supplier quality performance against QTAs, SLAs, and KPIs, conducting periodic supplier quality reviews, and directing corrective action when performance deviates from expectations.

Seeking and interpreting regulatory expectations for outsourced activities and supplier oversight (e.g., EU GMP Chapter 7 and Annex 11, 21 CFR Part 11, ICH Q9(R1) and Q10, ICH E6(R3)) and translating them into controlled procedures and supporting policies.

Representing computerized system supplier oversight during health authority inspections and audits, demonstrating that Lilly retains accountability for outsourced GxP activities.

Serving as a point of escalation for GISQ CSQA representatives and business partners on supplier quality matters, including supplier-related deviations, supplier change notifications, and unresolved audit findings.

Partnering with Procurement, Legal, Cyber Security, Privacy, and Tech@Lilly sourcing/vendor management to integrate quality requirements into the full supplier lifecycle, from selection and onboarding through exit.

Serving as a member of the GISQ Technical Review Board, providing direction on enterprise-wide computer system discussions and coaching/mentoring across the network.

Key Objectives/Deliverables

Supplier and Third-Party Quality Oversight

Managed-Service Oversight: For outsourced CSV and managed-service providers, oversee the quality obligations within contracts and statements of work (SOWs), supplier performance, service planning, continuity of knowledge and staffing, and transition obligations.

Assessments: Oversee the risk-assessment process (on-site, remote, and questionnaire-based assessments), leveraging independent certifications and attestations (e.g., ISO 9001, ISO/IEC 27001, SOC 2 Type II) where appropriate, and issue reports within defined timelines.

Assessment Observations and Reports: Classify observations, evaluate supplier responses and CAPA plans, verify effectiveness, and track findings to closure.

Quality Technical Agreements: Author, negotiate, approve, and periodically review QTAs that define GxP responsibilities such as change and release notification, incident and security breach notification, data integrity, backup and restore, record retention, audit rights, subcontractor management, and data return and deletion at exit.

Supplier Changes and Subcontractors: Ensure supplier-initiated changes (e.g., SaaS releases, infrastructure changes, subcontractor changes) are received and assessed for impact to the validated state, in partnership with the CSV Common Process Lead and system owners.

Maintain Inspectional Readiness

Ensure supplier qualification records, audit reports, QTAs, and supplier performance evidence are current, complete, and retrievable for inspections.

Ensure all quality actions and commitments related to supplier oversight are appropriately tracked in Quality/CAPA plans and completed on time.

Provide periodic updates to GISQ leadership and key stakeholders on the supplier risk profile, audit program status, open observations, and emerging supplier risks.

Deliver Projects, Programs, and Support

Provide consultation/interpretation on computer system procedures related to supplier management, while appropriately escalating computer system quality issues.

Be a GISQ/Tech@Lilly process owner for computerized system supplier management procedures.

Connect with and influence other QMS groups (e.g., GxP supplier quality and audit functions) and Procurement’s third-party risk processes to harmonize supplier oversight and avoid duplicate audits.

As part of ‘account management’, create and maintain periodic touchpoints with strategic suppliers and internal service owners to discuss trends, performance, upcoming changes, and areas of concern.

Review/approve documents per CSV expectations within agreed service levels, or clearly communicate when activities will be completed.

Streamline and Continuously Improve

Eliminate non-value-added activities in supplier oversight by right-sizing assessment depth and frequency to risk.

Standardize QTA templates, audit checklists, and assessment questionnaires by service model to reduce cycle time and improve consistency.

Understand external trends and potential ramifications for the supplier base and supported IT area(s).

Grow Capabilities and Knowledge

Liaise and develop networks with other Quality organizations (e.g., BQA, GxP supplier quality and audit functions).

Share lessons learned from audits and supplier events, and best practices, with others in GISQ and across the enterprise, coaching and mentoring others on technical matters to build on Lilly’s Quality culture.

Be proactive in benchmarking supplier oversight practices both internal and external to Lilly.

Minimum Requirements

• Bachelor degree in a science, engineering, computer science/systems, or pharmaceutical-related field; or equivalent experience.
• Prior role experience in Computer System Validation, including working knowledge of GAMP 5, 21 CFR Part 11, EU GMP Annex 11, and regulatory expectations for outsourced activities and supplier oversight.
• Prior role experience planning, leading, and reporting assessments of computerized system suppliers or IT service providers, including managing observations through closure.
• Prior role experience authoring or negotiating Quality Technical Agreements and defining quality-relevant SLA requirements in partnership with Procurement and Legal.
• Prior role experience managing supplier or managed-service relationships, including contracts, SOWs, and performance management, without formal people-management responsibility.
• Working knowledge of cloud and outsourced service models (SaaS, PaaS, IaaS, managed services) and their shared-responsibility implications for GxP compliance.
• Experience supporting health authority inspections and audits, including coordinating evidence retrieval and defending the company position on supplier oversight.
• Sustained ability to contribute and influence at the AVP/IO level and with supplier leadership.
• Demonstrated strong oral and written communication, negotiation, and interpersonal skills, and ability to influence and collaborate.
• Ability to focus across multiple processes (end-to-end viewpoint).

Additional Preferences

• Practical application of IT-control related certifications (e.g., CISA, ISO, ITIL, CSQE (ASQ, QAI)).
• Prior experience with Lilly Quality Systems (deviations, analytical investigations, change, and/or complaints) and third-party risk management processes.
• Global experience, including oversight of international suppliers and service providers.
• Knowledge of IT Best Practices (e.g., LSEF, ITIL), particularly service-level and service-management practices.
• Broad IT technical competency, to include emerging technologies (e.g., Cloud, Machine Learning, Artificial Intelligence, etc.).
• Ability to relate supplier performance and system use to potential impact to products and patients.
• A track record of building resilient supplier relationships through continuity planning, cross-training, and disciplined knowledge transfer.
• Ability to work effectively in a diverse, multicultural environment and adapt communication style accordingly.
• Strong influence-without-authority skills, given the cross-functional, individual-contributor nature of this role.
• Membership and active participation in external forums/organizations.

Other Information

• This is an individual contributor role with no direct people-management responsibility.
• Must complete Lilly’s CSQA Qualification Program and applicable Lilly auditor qualification prior to leading supplier audits.
• The position is based in Indianapolis, Indiana. Travel is required to support supplier audits and may include international 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

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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