Sr. Associate

3 weeks ago

Cork, Cork, Ireland Eli Lilly and Company Full time

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. Our 45,000 employees 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. Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions across various Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace 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 enhance the career experience for our colleagues. Eli Lilly Cork is committed to diversity, equity and inclusion (DEI) with a focus on all dimensions including ethnicity, nationality, cultural backgrounds, generations, sexuality, disabilities and gender.

Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself

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. This role acts as a quality consultant and leader in integrating quality requirements into business processes, implementing the quality plan, and ensuring consistency between global and local requirements.

Primary Responsibilities:1. Implement and Manage Quality Systems
  1. Contribute to the development and review of country/region specific quality system documents.
  2. Approve regional and/or local required tools, resources, forms, and templates.
  3. Assist in interpreting relevant regulations and guidelines.
  4. Recommend new procedures or changes to existing procedures.
  5. Responsible for deviations, change controls, ensuring events are documented, escalated, and completed.
  6. Conduct root cause analysis and implement Corrective Action and Preventative Action (CAPA) process.
  7. Support the business on the application and facilitation of quality systems.
  8. Support activities related to external party management.
  9. Perform quality self-assessments as needed.
2. Provide Quality Oversight for business area(s)
  1. Monitor and provide quality oversight for compliance to Safety & Efficacy Quality System (SEQS).
  2. Communicate and escalate compliance issues to management.
  3. Provide consultation on interpretation and application of external requirements.
  4. Ensure implementation of regional and/or affiliate Quality Plan(s).
  5. Analyze trends, identify weaknesses/gaps, and recommend corrective actions.
  6. Monitor completion of quality related required actions.
  7. Provide input into risk assessments, audit planning, and quality plans.
  8. Share key learning to drive simplification and replicate best practices.
  9. Coordinate quality improvement initiatives.
3. Audits and Inspections
  1. Facilitate audits/inspections.
  2. Manage audit and/or inspection responses.
  3. Ensure inspection readiness requirements are in place.
  4. Ensure completion of audit or inspection CAPA plans.
4. Partnership with other area(s)
  1. Act as the initial point of consultation for business areas on quality related questions.
  2. Partner with business area(s) to strengthen quality controls.
  3. Share key learning to drive simplification.
  4. Collaborate with other quality groups as appropriate.
  5. Establish good working relationships with assigned business area(s).
  6. Participate in team, business, and quality related meetings.
  7. Utilize a risk-based approach in guiding business areas.
  8. Support key projects as assigned.
5. Other responsibilities
  1. Understand the handling of confidential information.
  2. Understand the role and responsibility of the EU Qualified Person for Pharmacovigilance (EU QPPV).
Minimum Qualification Requirements:
  1. Bachelors in a science or health care related field.
  2. Three years' experience in quality and/or drug product safety/regulatory.
  3. Demonstrated ability to implement, interpret and apply quality systems.
  4. Cognitive abilities including problem solving, verbal reasoning, attention to detail, critical thinking, and analytical competencies.
  5. Demonstrated ability to communicate effectively and influence others.
  6. Demonstrated ability to prioritise and handle multiple concurrent tasks.
  7. Demonstrated ability to apply risk-based decision making.
Other Information/Additional Preferences:
  1. Master's degree or above.
  2. Five years experience or more in quality and/or drug product safety/regulatory.
  3. Demonstrated ability to work in a global environment.
  4. Cultural sensitivity.
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