Eli Lilly and Company is a global healthcare leader dedicated to making life better for people around the world. Our employees work together 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 value diversity, equity, and inclusion (DEI) and strive to create an environment where all dimensions are included. Our four pillars - EnAble, Age & Culture, LGBTQ+, and GIN-Gender Inclusion Network - ensure that everyone feels valued and respected.
Purpose
The Senior Associate/Principal Associate – Global Medicines Quality Organisation (GMQO) representative plays a critical role in supporting the development and implementation of quality systems and activities to achieve business goals and objectives.
This quality role will support Global Regulatory Affairs (GRA), which develops and executes regulatory strategy and leads interactions with regulators. This includes monitoring changing legislation, submitting reports, summaries, and labeling as part of marketing applications to regulatory agencies.
Primary Responsibilities
1. Implement and Manage Quality Systems
* Contribute to the development of GRA procedures and required tools, resource documents, and supplemental materials, including review and content approval (as assigned) of quality system documents.
* 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. Anticipates gaps and proactively proposes solutions.
* 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.
Minimum Qualification Requirements
* Bachelor's Degree in a regulatory/science/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 drug product safety/regulatory.
* Experience in a quality control/quality assurance role.
* Ability to work independently and as part of a team.
* Demonstrated ability to work in a global environment.