Senior Clinical Quality Lead - Oncology

Eli Lilly and Company • Indianapolis, IN

1d • $65,250 - $169,400 • Hybrid

About The Position

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. Purpose: The Senior Clinical Quality Lead – Oncology serves as the quality expert for their assigned area (regional/affiliate, portfolio, and/or functional business units). The role contributes to strategic planning to enhance the effectiveness of the Safety and Efficacy Quality System (SEQS), integrates quality into business processes, leads quality initiatives, and provides guidance to teams. Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The responsibilities of any position may evolve over time and may include additional duties not specifically described in the job description. Functional and Technical Expertise Familiar with regulations and guidelines, provides interpretation, direct input into quality systems and defines the quality direction to comply with external and internal expectations. Provides key input into the design of the Quality System and leads implementation into the business area with accountability for the implementation and delivery of milestones for the quality system. Guides the business on regulatory execution at local, regional, and global levels to ensure compliance and inspection readiness. Accountable for the development and implementation of the quality strategy for the portfolio and functions, partnering with business to complete quality risk assessments and develop a risk management plan. Performs on-going risk assessment and evaluation of the quality of the quality system to identify performance/compliance gaps relative to current regulations and company standards, guidelines and internal procedures and recommends robust corrective actions. Engage in proactive data analysis for the area assigned to identify emerging issues, trends, and opportunities, contributing to informed decision-making and continuous improvement within the business area. Expert in corrective and preventative actions (CAPA) management. Ensure deviation/change management, root cause investigation and corrective/preventive actions are managed, documented, escalated, and completed. Reports issues through Notification to Management (NTM) as appropriate Contributes risk-based input to Global Quality Auditing and Compliance (GQAAC) audit planning. Defines, executes, and documents quality self-assessments checks/self-inspections and discusses output with business partners. Acts as Business Quality Assurance (BQA) for critical business and IT systems, including review and approval of system-related documentation and partnership on system changes. Provides quality oversight and consultation for assigned SEQS components, collaborating cross-functionally with stakeholders such as Legal, Compliance, Finance, Clinical Design, Delivery, and Analytics. Inspection Readiness and Inspection Management Leads pre-inspection preparation activities in collaboration with business partners. Prepares and educates internal and external customers/business partners (including investigator site staff) on inspection management. Actively supports regulatory inspections (PV, site, and sponsor inspections). Coordinate and manage audits/inspections effectively, including backroom and front room support, as required. Responsible for audit and inspection response management, coordination, documentation, and tracking through resolution. Actively participates in lessons learned/shared learning sessions regarding clinical trial site support during inspections, as applicable to role. Influence Quality Direction Leads the direction of quality for supported area/function and works with other consultants to ensure consistent practices are employed. Provides technical and team leadership for quality, portfolio, medical affairs, and divisional projects. Ability to engage and influence leadership across organizations (Legal, Compliance, Finance, CDDA, Regulatory, Safety, Medical Affairs, External Partners/Customers, etc.) to resolve complex issues. Leads the team to deliver innovative solutions, preventing re-occurrence of issues. Utilizes quality experience to support change management and business transformation in the delivery of critical business priorities. Problem Solving Leads teams in the process of resolution of issues; including resolution of conflict and building an environment to focus on the resolution of issues. Escalates issues and manages the interfaces to ensure issues are resolved. Raises issues to management, including issues that could have the ability to impact critical business areas. Develops well thought out solutions and presents clear action plans. Quality Technical Leadership Provides key data (compliance, conformance, risks, issues) to senior management to drive decision making in support of the business area assigned. Initiates, drives, and coordinates quality improvement initiatives across affiliate, site(s), or functions. Key resource in the development of new business process and partnerships - developing quality agreements and directing management of key steps required to ensure quality, including evaluating (risk assessment or vendor assessment) the partnership (third party or alliance), the program and setting forth the quality direction and approving oversight plans. Leads the harmonization of best practices and projects across the regions, functions and other Quality organizations and recommends key projects. Project Management Engages and mobilizes cross functional and geographical work teams to deliver projects successfully - influences assignment of resources to enable project progress. Utilizes project planning and maximizes the use of the Six Sigma methodology to achieve project results. Builds innovative, simple, and workable solutions to solve business problems. Customer/External Focus Sets the quality expectation for third party partners and advises on requirements and inspection needs. Acts as quality expert consultant to the business and external parties. Builds relationships with internal and external customers and partners. Manages audits and regulatory inspections in cross-functional company areas, across regions and with external partners.

Requirements

• Bachelor’s Degree - Preferred in a science/technology/health care related field
• Minimum 5 years’ experience – Preferred in biotech, pharmaceutical or clinical research, or quality.
• Qualified applicants must be authorized to work in the United States on a full-time basis.
• Lilly will not provide support for or sponsor work authorization and/or visas for this role.

Nice To Haves

• Strong preference for experience in conducting and managing early and/or late phase oncology clinical trials
• Extensive knowledge of GxP regulations, guidelines, and standards.
• Project management experience.
• Excellent communication (written and verbal), interpersonal, organizational and negotiation skills.
• Proven ability to work effectively across global, cross‑functional teams and at all organizational levels.
• Strong problem-solving skills, including root cause analysis and management of complex global quality issues with sound judgment.
• High initiative and ability to distinguish critical from non‑critical issues.
• Proficient written and spoken English language skills.

Responsibilities

• Familiar with regulations and guidelines, provides interpretation, direct input into quality systems and defines the quality direction to comply with external and internal expectations.
• Provides key input into the design of the Quality System and leads implementation into the business area with accountability for the implementation and delivery of milestones for the quality system.
• Guides the business on regulatory execution at local, regional, and global levels to ensure compliance and inspection readiness.
• Accountable for the development and implementation of the quality strategy for the portfolio and functions, partnering with business to complete quality risk assessments and develop a risk management plan.
• Performs on-going risk assessment and evaluation of the quality of the quality system to identify performance/compliance gaps relative to current regulations and company standards, guidelines and internal procedures and recommends robust corrective actions.
• Engage in proactive data analysis for the area assigned to identify emerging issues, trends, and opportunities, contributing to informed decision-making and continuous improvement within the business area.
• Expert in corrective and preventative actions (CAPA) management.
• Ensure deviation/change management, root cause investigation and corrective/preventive actions are managed, documented, escalated, and completed.
• Reports issues through Notification to Management (NTM) as appropriate
• Contributes risk-based input to Global Quality Auditing and Compliance (GQAAC) audit planning.
• Defines, executes, and documents quality self-assessments checks/self-inspections and discusses output with business partners.
• Acts as Business Quality Assurance (BQA) for critical business and IT systems, including review and approval of system-related documentation and partnership on system changes.
• Provides quality oversight and consultation for assigned SEQS components, collaborating cross-functionally with stakeholders such as Legal, Compliance, Finance, Clinical Design, Delivery, and Analytics.
• Leads pre-inspection preparation activities in collaboration with business partners.
• Prepares and educates internal and external customers/business partners (including investigator site staff) on inspection management.
• Actively supports regulatory inspections (PV, site, and sponsor inspections).
• Coordinate and manage audits/inspections effectively, including backroom and front room support, as required.
• Responsible for audit and inspection response management, coordination, documentation, and tracking through resolution.
• Actively participates in lessons learned/shared learning sessions regarding clinical trial site support during inspections, as applicable to role.
• Leads the direction of quality for supported area/function and works with other consultants to ensure consistent practices are employed.
• Provides technical and team leadership for quality, portfolio, medical affairs, and divisional projects.
• Ability to engage and influence leadership across organizations (Legal, Compliance, Finance, CDDA, Regulatory, Safety, Medical Affairs, External Partners/Customers, etc.) to resolve complex issues.
• Leads the team to deliver innovative solutions, preventing re-occurrence of issues.
• Utilizes quality experience to support change management and business transformation in the delivery of critical business priorities.
• Leads teams in the process of resolution of issues; including resolution of conflict and building an environment to focus on the resolution of issues.
• Escalates issues and manages the interfaces to ensure issues are resolved.
• Raises issues to management, including issues that could have the ability to impact critical business areas.
• Develops well thought out solutions and presents clear action plans.
• Provides key data (compliance, conformance, risks, issues) to senior management to drive decision making in support of the business area assigned.
• Initiates, drives, and coordinates quality improvement initiatives across affiliate, site(s), or functions.
• Key resource in the development of new business process and partnerships - developing quality agreements and directing management of key steps required to ensure quality, including evaluating (risk assessment or vendor assessment) the partnership (third party or alliance), the program and setting forth the quality direction and approving oversight plans.
• Leads the harmonization of best practices and projects across the regions, functions and other Quality organizations and recommends key projects.
• Engages and mobilizes cross functional and geographical work teams to deliver projects successfully - influences assignment of resources to enable project progress.
• Utilizes project planning and maximizes the use of the Six Sigma methodology to achieve project results.
• Builds innovative, simple, and workable solutions to solve business problems.
• Sets the quality expectation for third party partners and advises on requirements and inspection needs.
• Acts as quality expert consultant to the business and external parties.
• Builds relationships with internal and external customers and partners.
• Manages audits and regulatory inspections in cross-functional company areas, across regions and with external partners.

Benefits

• employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level