Sr. Associate / Principal Associate - Medicines Quality Organization (R1-R3

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 Eli Lilly Cork, 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 45,000 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 2000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork 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. Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!

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.

MINIMUM QUALIFICATION REQUIREMENTS:

• Bachelors in a science or health care related field, Healthcare 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.

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.

5. 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.