R&D Clinical - Quality Compliance Senior Manager

Amgen · Hyderabad, India

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Clinical OperationsFull-timeCompany career page

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Role summary

Amgen seeks a Senior Manager for R&D Clinical Quality Compliance in Hyderabad to provide comprehensive quality oversight throughout clinical trial lifecycles. The role focuses on implementing risk-based quality management and quality-by-design principles, ensuring GCP compliance, and supporting regulatory submissions and inspections.

What they're looking for

Master's degree in Life Sciences, Medical, or related discipline
15-18 years experience in biotech, pharmaceutical, or CRO companies
In-depth knowledge of ICH GCP guidelines and regulatory procedures
Extensive quality management experience with risk-based and quality-by-design methodologies
Proficiency with electronic QMS platforms such as Veeva Vault and eTMF
Strong communication skills in English and analytical decision-making abilities
Demonstrated capability with AI tools for process automation and data analysis

What you'll be doing

Serve as key quality advisor to clinical study teams throughout trial lifecycle with independent compliance input
Review clinical protocols and amendments for quality-by-design fit, clarity, and consistency
Analyze quality data metrics and participate in risk-based quality management activities
Oversee compliance for global clinical trials and support inspection readiness preparation
Conduct monthly reviews with study leadership on quality issues, trends, and audit planning

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Date posted16 days ago

Last source check1 day ago

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