Junior Responsible Manager Delegate for Clinical Trial Materials at Eli Lilly and Company

Istanbul, Istanbul, Turkiye

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

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, with ability to interpret and apply them for 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

Responsibilities

Act as delegated Responsible Manager to perform quality checks for the release of 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
Ensure compliance with local Good Clinical Practice (GCP) Quality System and applicable Türkiye MOH regulations
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 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 returned products, ensure potential quality issues or failures are reported appropriately, and coordinate if new provisions apply
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 to clinical teams and affiliate Responsible Manager
Understand performance metrics related to CT materials and identify areas for improvement and simplification
Understand SOPs and processes for CT materials

Skills

GCP

Quality Assurance

Pharmaceutical Quality

Regulatory Compliance

Deviation Management

Change Management

Root Cause Analysis

CAPA

Microsoft Office

English Fluency

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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