Sr. Associate - Medicines Quality Organisation

at  Lilly

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.
Associate / Senior (Sr) Associate / Principal Associate
Medicines Quality Organisation (MQO) (R1-R3) / R4

JOB DESCRIPTION:

The purpose of the Associate / Sr Associate / Principal Associate – MQO International role is to support the development and implementation of quality systems strategy and activities to support International Business Unit (IBU) goals and objectives for assigned countries or regions.
In support of this mission, the purpose of this role within an Affiliate/Region is to act as a quality consultant and leader in integrating the quality requirements into the business processes. The role will implement the quality plan and ensure consistency between the global requirements and local requirements. This includes the implementation of Safety and Efficacy quality system/procedures and assuring that this system/procedures is aligned with appropriate quality and regulatory requirements. Provide updates on internal/external GxP trends and changes through the country/regional affiliate leadership team(s). Acting as a contact person regarding quality and business process compliance concerns between affiliates and global.
Primary Responsibilities: This job description is intended to provide a general overview of the job requirements.

AUDITS AND INSPECTIONS

• Facilitate audits/inspections (for example, preparation/readiness, coordination, back room, front room, responses).
• Manage audit and/or inspection responses
• Communicate and ensure inspection readiness requirements are in place, being organisation and availability of documents such as training records, job description, backroom and/or front room organization.
• Ensure completion of audit or inspection CAPA plans and timely resolution.

MINIMUM QUALIFICATION REQUIREMENTS:

• Bachelor’s or Master’s degree in a science or health care related field, Health care professional, such as: Pharmacist, Nurse.
• Three years experience in quality and/or clinical operations, drug product safety/regulatory.
• Demonstrated ability to implement, interpret and apply quality systems within a regulated work environment (such as GMP, GCP, GVP).
• Cognitive abilities which include problem solving, verbal reasoning, attention to detail, critical thinking and analytical competencies
• Demonstrated ability to communicate effectively, both written and verbal, and to influence others.
• Demonstrated ability to prioritise and handle multiple concurrent tasks.
• Demonstrated ability to apply risk-based decision making in a regulated environment.

• Understand the handling of confidential information (patient privacy, confidential audits and regulatory inspections)
• Understand the role and responsibility of the EU Qualified Person for Pharmacovigilance (EU QPPV) and as applicable, any locally required pharmacovigilance qualified person role.