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Job Description
Job Summary:
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.
About the Role:
As a key member of the Medicines Quality Organisation (MQO) team, you will play a critical role in ensuring the quality of our medicines and products. You will work closely with cross-functional teams to develop and implement quality systems, ensuring compliance with regulatory requirements and industry standards.
Key Responsibilities:
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Implement and Manage Quality Systems:
- Contribute to the development and review of quality system documents to ensure requirements and accountabilities are represented.
- Approve regional and/or local required tools, resources, forms, templates.
- Assist in interpreting relevant regulations and guidelines and act as a contact person for global and affiliates.
- Recommend new procedures or changes to existing procedures where applicable.
- Responsible for deviations, change controls, Notification to Management (NTM), ensuring events are appropriately documented, escalated, and completed.
- Conduct root cause analysis and implement Corrective Action and Preventative Action (CAPA) process.
- Support the business on the application and facilitation of quality systems (deviations, notification to management, change control).
- Support activities and processes related to external party management (such as, third-party organizations, business alliance partners) as assigned.
- Perform quality self-assessments, as needed.
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Provide Quality Oversight for Business Area(s):
- Monitors and provide quality oversight for compliance to Safety & Efficacy Quality System (SEQS).
- Communicates and escalates compliance issues to management locally and globally, as appropriate.
- Provide consultation on the interpretation and practical application of external requirements, standards, and procedures.
- Ensure implementation of regional and/or affiliate Quality Plan(s) as necessary. Monitor progress of actions and provide updates to business and quality leadership.
- Analyze trends, identify areas of weaknesses/gaps and recommend corrective actions.
- Monitor completion of quality related required actions such as: CAPA associated with deviations, change controls, audit or inspection commitments.
- Provides input into risk assessments, audit planning and/or quality plans based on identified signal/risks/gaps.
- Share key learning to drive simplification and replicate best practices in the region and globally.
- Coordinate quality improvement initiatives.
- Seek and implement simplification and process improvement.
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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.
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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.
- Utilize a risk-based approach in guiding business areas.
- Support key projects as assigned.
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Other Responsibilities:
- 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.
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 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.
About Lilly:
Lilly is 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.