Senior) Associate

vor 23 Stunden

Bad Homburg vor der Höhe, Deutschland Lilly Vollzeit

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.

Your responsibilities:

- ** 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.

Your Profile:

- ** 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.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

WeAreLilly

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