Lead Global Medical Quality - Statistics

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.

The purpose of the Lead/Senior Lead, GMQO is to support the development and implementation of the strategy for quality systems and activities to support business goals and objectives. This includes execution of quality system deliverables to ensure compliance, quality oversight of business areas to integrate requirements, audit/inspection support and collaboration within quality and Statistics.
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* Primary Responsibilities:

**** Implement and Manage Quality Systems
*** Contribute to the development of area specific procedures and required tools, resource documents and supplemental materials, including review and content approval (as assigned) of quality system documents.  Ensures the regional and/or affiliate quality system requirements have clear accountabilities, as assigned.
* Recommends new quality system documents or changes to existing quality system documents where applicable.
* Advise on appropriate training for implementation and documentation.
* Provide consultation on the interpretation and practical application of external requirements, standards, and procedures.
* Responsible for deviations, change controls, Notification to Management (NTM), ensuring events are appropriately documented, escalated, and completed.
* Consult on root cause analysis and corrective/preventive actions (CAPA) including review/approval as necessary.
* Provides input into risk assessments, audit planning and/or quality plans based on identified signal/risks/gaps.
* Complete self-inspections and drive improvements that are meaningful and actionable
* Ensure local implementation of the quality systems as necessary.
* Provides support related to external party management (for example, third-party organizations, business alliance partners) as assigned.
** Provide Quality Oversight for the Statistics business area
*** Monitor for compliance to quality system documents.  Anticipates gaps and proactively proposes solutions.
* Communicates and escalates to management as appropriate.
* Ensure implementation of regional and/or affiliate Quality Plan(s) as necessary. Monitor progress of actions.
* Provide updates to quality and business owners.
* Seek and implement simplification and process improvement.
* Coordinate quality improvement initiatives.
* Review metrics and trending to improve processes and compliance, as assigned.

Compile compliance metrics and maintain metrics process (for example, periodic report metrics).Analyze trends, identify areas of weaknesses/gaps and recommend corrective actions (for example, PRAC assessment reports).Monitor completion of deviations, change controls, CAPA, audit responses.
** Audits and Inspections
*** Provide support for audits/inspections (for example,  preparation/readiness, coordination, back room, front room, responses).
* Communicate and ensure inspection readiness (for example, organization and availability of documents such as training records, job descriptions)
* Ensure completion of audit corrective action plans and timely resolution.
* Leads and/or supports readiness activities in collaboration with business partners.
** Partnership with the Statistics business area
*** Functions as the initial point of consultation for the Statistics business area on quality related questions.
* Partners with the Statistics business area to strengthen and ensure appropriate quality controls are in place.
* Shares key learning to drive simplification and replicate best practices
* Collaborates with other quality groups as appropriate and develops quality network.
* Establishes good working relationships with the Statistics business area.
* Actively participates in team, business and quality related meetings.
* Supports issue resolution including escalation.
* Utilize a risk-based approach in guiding business areas.
* Support key projects as assigned.
* Understand the roles and responsibilities of the EU Qualified Person for Pharmacovigilance (EU QPPV), if applicable.
* Serve as an IT systems business quality assurance (BQA) representative for IT systems, as assigned.

Perform all responsibilities of IT Business Quality as defined in Computer System Policies and Procedures.

Review and approve as appropriate, documents associated with the development and maintenance of IT systems as the representative of MQO, Regulatory Quality.

Partner with IT and the business on system related initiatives/changes as the BQA for assigned IT systems.
** Minimum Qualification Requirements:
*** Bachelor’s Degree in a…