Junior Responsible Manager Delegate for Clinical Trial Materials

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.

Ensure compliance with local Good Clinical Practice (GCP) Quality System as well as compliance with applicable Türkiye MOH regulations.

Technical Training, Personal Skills And Experience Required

• A university degree in Pharmacy from Türkiye.
• Minimum 2 years’ experience in quality assurance applied to the pharmaceutical industry.
• Working knowledge of GCP regulations and quality system implementation and the ability to interpret and apply them for Quality Assurance (QA) responsibilities
• Fluent in English (conversational, writing and reading) Knowledge and mastery of basic computing tools (Microsoft office).
• Good interpersonal relations Ability to train working groups.
• Good analytical skills and attention to details.
• High initiative, learning agility and a flexible, positive attitude.
• High degree of accuracy and attentive to details.
  
  
  

The Responsible Manager Delegate for Clinical Trial Materials is responsible for:

• Act as delegated Responsible Manager to Perform Quality checks for the release of the Clinical Trial Products upon arrival to Türkiye.
• Release clinical trial product shipments that meet all quality specifications and local regulations as a delegated Responsible Manager.
• Support inspection readiness activities for MOH inspections. Assure that deviations, change management processes, root cause investigations, and corrective/preventive actions are effectively managed, documented, escalated, and completed in a timely manner.
• Monitor compliance with the external party which is responsible for storage and distribution of Clinical Trial Materials.
• Assist on training programs to external vendors which might have impact on Clinical Trial Material operations.
• Review the returned products, ensure that any potential quality issue or failure that could have originated the return will be reported appropriately and coordinate if new provision applies to these products Support Quality Manager on reviewing/ updating Quality Agreements related to Clinical Trial Products Act as a point of contact for quality release of clinical trial materials in Türkiye affiliate.
• Provide appropriate escalation of issues clinical teams and affiliate Responsible Manager.
• Understand performance metrics related to CT material and identify areas for improvement and simplification.
• Understand SOPs and processes for CT materials.
  
  
  

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