Associate/Sr. Associate Medicines Quality Organisation (MQO) - Trial Capabi

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.
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 39,000 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 patients around the world.
Eli Lilly Cork, is made up of a talented diverse team of over 1,600 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.
Lilly offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!

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 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.

3. 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

PURPOSE:

The purpose of the Associate / Sr Associate MQO - Trial Capabilities 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 and assuring that this system 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:

1. Implement and Manage Quality Systems

• Contribute to the development and review of country/region specific 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.

1. 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

1. 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.

1. 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.

1. 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.