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.
Based in Geneva, Eli Lilly Export SA focuses on distributing pharmaceutical products in small to medium-sized markets across the globe, ensuring critical medical needs of patients are met.
To reinforce our Quality Assurance department, we are looking for a (Sr.) Associate - Quality Assurance
Purpose of the Position
The (Sr.) Associate – Quality Assurance is responsible, in collaboration with the “Responsable Technique,” for the implementation, maintenance, and continuous improvement of the Quality Management System (QMS) for the Geneva-based Trading Companies. This role ensures compliance with Swiss health regulations and Lilly Global Quality Standards.
The position involves managing quality issues and decisions, supporting regulatory compliance, and driving quality system enhancements. It requires strong cross-functional collaboration, independent project leadership, and the ability to provide expert guidance on complex quality matters.
Key Responsibilities
Quality System Management
- Support implementation and maintenance of QMS elements (e.g., SOPs, quality manual, quality plan).
- Review and approve GxP-relevant procedures, job aids, and training materials.
- Manage Change Control, Deviation, and CAPA systems.
- Support processes for product complaints, recalls, returns, falsified products, and notifications to management.
- Conduct and approve GMP/GDP training and personnel qualification activities.
- Identify system gaps and lead continuous improvement initiatives.
Compliance & Regulatory Oversight
- Ensure QMS compliance with Swiss regulations, Lilly Global Quality Standards, and Common Quality Practices.
- Maintain data integrity of quality records.
- Prepare and manage Quality Agreements.
- Support inspections, audits, and self-inspections, including readiness and follow-up.
- Conduct quality risk assessments and impact evaluations for deviations and changes.
- Monitor licenses and authorizations for customers, suppliers, and outsourced activities.
Business & Cross-Functional Support
- Act as a quality liaison between commercial, supply chain, and other Lilly entities.
- Provide guidance on quality issues in collaboration with QA leadership and global teams.
- Participate in local and global projects, assessing quality impact and ensuring compliance.
- Train new employees on GxP processes and local procedures.
IT & Data Stewardship
- Oversee quality-related activities in GBIP/SAP, including overrides and quality data management - act as Geneva QM Data Steward.
- Manage DSP-M and DSP-C requests for material and customer master data.
- Ensure global systems for change control and deviations are used in accordance with defined processes.
Communication & Influence
- Represent the Geneva Quality team in internal and external engagements.
- Foster effective communication within the QA team and across Lilly functions.
- Influence cross-functional teams and drive alignment on quality matters.
Candidate Profile
Technical Skills
- Scientific background (Pharmacy, Chemistry, Biology, or Veterinary).
- Strong knowledge of GMP/GDP and pharmaceutical quality systems.
- Recognized as a subject matter expert in quality assurance.
Soft Skills
- Strong analytical and decision-making abilities.
- Excellent communication and interpersonal skills.
- Attention to detail, flexibility, and cultural awareness.
- Proven ability to lead and manage projects independently.
Experience & Education
- Minimum 3–5 years of experience in Quality Assurance, Compliance, Regulatory, or Laboratory roles.
- Experience in a pharmaceutical company is a strong asset.
Languages
- Fluent in English and French; additional languages are a plus.
IT Proficiency
- Very good knowledge of Microsoft Office and SAP.
Location
Geneva, Switzerland - Contract is subject to a valid work permit in Switzerland.
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.
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.
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