Senior Clinical Quality Lead - Oncology

Location: Indianapolis

Senior Clinical Quality Lead - Oncology page is loaded## Senior Clinical Quality Lead - Oncology locations:
US, Indianapolis IN:
US, Remote time type:
Full time posted on:
Posted Todayjob requisition :
R-100057

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.
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* 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.
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* 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…