At Eli Lilly and Company, 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.
The Senior Associate/Principal Associate – Global Medicines Quality Organisation (GMQO) representative will 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 other areas.
This Quality role will support the Clinical Trial Foundations (CTF) team in the strategy and development of contemporary clinical trial processes, technologies, information, and capabilities and in shaping external policy and guidance to speed the delivery of medicines to patients globally.
Purpose
The purpose of this role is to provide strategic support to the GMQO and CTF teams in developing and implementing quality systems and processes that align with business goals and objectives.
Primary Responsibilities
This role will have several key responsibilities:
1. Implement and Manage Quality Systems
* Contribute to the development of CTF procedures and required tools, resource documents and supplemental materials.
* Recommend 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.
2. Provide Quality Oversight for business area(s)
* Monitor for compliance to quality system documents.
* Communicates and escalates to management as appropriate.
* Ensure implementation of 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.
Analyze trends, identify areas of weaknesses/gaps and recommend corrective actions.
Monitor completion of deviations, change controls, CAPA, audit responses.
3. 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.
4. Partnership with other area(s)
* Functions as the initial point of consultation for business areas on quality related questions.
* Partners with the business area(s) 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 assigned business area(s).
* 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.
* 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 science/technology/health care related field or equivalent work experience.
* Demonstrated ability to apply quality systems within a regulated work environment.
* Effective project and time management skills.
* Demonstrated ability to communicate effectively, both written and verbal, and to influence others.
* Demonstrated ability to prioritize and handle multiple concurrent tasks.
* Cognitive abilities which include problem solving, verbal reasoning, attention to detail, critical thinking and analytical competencies.
* Strong interpersonal skills with demonstrated flexibility in varying environments/geographies.
* Effective organization/self-management skills.
Other Information/Additional Preferences
* Master's degree or above.
* Five years' experience or more in quality and/or clinical trial processes and technology.
* Knowledge of quality systems.
* Knowledge of business systems support.
* Ability to work independently and as part of a team.
* Demonstrated ability to work in a global environment.