(Senior) Associate (m/w/d) - Global Medicines Quality.

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.

Come join us as as (Senior) Associate (m/w/d) - Global Medicines Quality.

This position is a hybrid role based in Germany, Switzerland or Austria.

Ihre Aufgaben

• Implement and Manage Quality Systems: approve tools for local use and develop country/region specific quality system documents, conduct root cause analyses, oversee CAPA processes and change control management.

• Provide Quality Oversight for Business Areas: monitor compliance with Safety & Efficacy Quality System (SEQS) in regulatory affairs and drug safety, analyse trends and implement regional quality plans.

• Audits and Inspections: Prepare for and facilitate audits/inspections, ensuring readiness of documentation and processes and manage responses to audit findings and ensure timely completion of CAPA plans.

• Crossfunctional collaboration: Serve as a primary contact for business areas on quality-related inquiries, enhance quality control and share best practices as well as coordination of quality improvement initiatives within the region.

• Training and Development: Provide mentoring for team members regarding quality systems and compliance processes.

• Confidentiality Management: Ensure the handling of confidential information in accordance with regulatory requirements.

Ihr Profil

• Educational Background: Bachelor's or Master's degree in a science or healthcare-related field (e.g., Pharmacist, Nurse), e.g. Pharmacovigilance.

• Experience: Demonstrated ability to implement and interpret quality systems within regulated environments (e.g., GVP, GCP) stemming from experience within quality assurance, or drug product safety/regulatory roles.

• Analytical Skill: Strong problem-solving abilities with attention to detail and critical thinking skills.

• Communication Skills: Excellent verbal and written communication skills with the ability to influence stakeholders effectively in German and English.

• Multitasking Ability: Proven capability to prioritize tasks and manage multiple projects concurrently maintaining excellent quality standards.

• Cultural Sensitivity: Experience working in a global environment with an understanding of cultural differences, willingness to support other regions as needed.

Kontakt

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.