Medicines Quality Representative

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.

Path/Level: 

R1-R3

PURPOSE

The purpose of the Associate/Senior Associate/Principal Associate – Global Medicines Quality (GMQO) representative role is to support the development and implementation of 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 functions located in the Asia Pacific Region. The role is to act as a quality leader and support the functions of Regulatory Affairs and Patient Safety.

KEY 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 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 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.

• Analyze trends, identify areas of weaknesses/gaps and recommend corrective actions, providing updates to management.

• 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 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.

• Understand the roles and responsibilities of the pharmacovigilance qualified person roles (such as the EU Qualified Person for Pharmacovigilance (EU QPPV), if applicable.

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

• Knowledge of GCP, ICH, FDA and other regulatory requirements

• 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 and Preferred requirements:

• Ability to read and write in English.

• Minimum of three years' experience in regulatory and/or pharmacovigilance

• Expertise in a quality control/quality assurance role

• Experience in defined functional business areas, for example, regulatory affairs, or pharmacovigilance

• Knowledge of quality systems

• Ability to work independently and as part of a team

• Demonstrated ability to work in a global environment

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 ) 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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