Sr. Associate Manager / Lead, GMQO

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 Associate / Senior Associate / Principal Associate – MQO 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 Clinical Development.

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 Clinical Development business area

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

Partnership with the Clinical Development business area

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

Other Information / Additional Preferences

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 does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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Skills Required

clinical development, Quality Systems