At Amgen, every challenge is an opportunity. At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achievetogetherresearching,manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.
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WHAT YOU WILL DO
We are hiring a R&D; Clinical Quality Compliance Senior Manager, who will operate in the Therapeutic Area Quality Department.
In this critical position, you will deliver comprehensive, proactive quality support throughout the relevant Therapeutic area clinical development program, contributing to the design and execution of a risk-based quality assurance strategy. This approach integrates quality by design principles and Risk Based Quality Management (RBQM) principles at every stage, from protocol development through database lock to regulatory submission and approval.
You will oversee quality management and verify compliance for globalclinical trials by supporting study teams involved in Amgen-sponsored Trials.
RESPONSIBILITIES
- Key advisor to the study team throughout the clinical trial life cycle, providing independent and objective quality input in the areas of GCP and compliance with Amgen SOPs and processes.
- Review and provide input into the development of the initial clinical study protocol and subsequent amendments, with focus on quality by design, confirming its fit for purpose, explicit, concise and consistent.
- Actively provide input into study risk assessment activities.
- Review and provide input into other key study documents and plans.
- Direct study teams through the management of complex quality issues
- Participate in key activities related to Risk Based Quality Management.
- Using available tools, analyze quality data metrics
- Monthly meetings with study team lead/associate director, to review th
📌 R&D Clinical (Hyderabad)
🏢 Amgen
📍 Hyderabad
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