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Sr. Associate / Lead / Senior Lead, Medicines Quality Organization

0-2 years
Not Disclosed
10 April 18, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Job Title:

Sr. Associate / Lead / Senior Lead, Medicines Quality Organization


Location:

Bangalore, Karnataka, India


Company:

Lilly


Job Description:

The Sr. Associate / Lead / Senior Lead in the Medicines Quality Organization (MQO) will support the development and implementation of strategies for quality systems, ensuring compliance, quality oversight, and collaboration across various business areas. The role focuses on quality system management, audits/inspections support, and continuous improvement initiatives to maintain high standards of quality.


Key Responsibilities:

  • Implement and Manage Quality Systems:

    • Contribute to the development of area-specific procedures and quality system documents.

    • Advise on training, interpretation of external standards, and application of quality systems.

    • Manage deviations, change controls, and CAPA processes.

  • Quality Oversight for Business Area(s):

    • Monitor compliance and propose solutions for gaps in quality systems.

    • Provide updates and ensure progress on quality improvement initiatives.

    • Compile compliance metrics and analyze trends for process improvement.

  • Audits and Inspections:

    • Provide support for audit/inspection preparation, coordination, and response.

    • Ensure inspection readiness by organizing relevant documents and ensuring timely completion of corrective actions.

  • Collaboration and Partnership:

    • Act as the point of consultation for business areas on quality-related matters.

    • Partner with business and quality teams to ensure appropriate quality controls.

    • Share best practices and drive process simplification.

  • Support Key Projects:

    • Participate in key quality and business meetings and support issue resolution.

    • Support IT systems quality assurance and collaborate on system-related initiatives.


Required Qualifications:

  • Education:

    • Bachelor’s Degree in a science, technology, or healthcare-related field, or equivalent work experience.

  • Experience:

    • Experience applying quality systems within regulated environments.

    • Experience in a quality control/quality assurance role is preferred.

    • Knowledge of quality systems, project, and time management.

  • Skills:

    • Strong communication skills (both written and verbal).

    • Problem-solving, attention to detail, and analytical competencies.

    • Ability to work independently and in a team.