Senior Associate, R&D Quality Compliance – Amgen | Hyderabad, India
Category: Quality
Work Model: On-site
Job ID: R-225413
Posted: October 31, 2025
Job Overview
Amgen, a global leader in biotechnology, is seeking a Senior Associate, Research and Development (R&D) Quality Compliance to support its growing Quality function within the Research & Development organization. This role plays a key part in ensuring operational compliance, inspection readiness, and effective oversight of clinical programs.
The position is based in Hyderabad, India, offering an opportunity to work within a world-class quality environment that supports continuous improvement, regulatory compliance, and high-quality clinical research practices.
Experience Required
Candidates must meet one of the following:
Master’s degree with 0–2 years of experience in Quality, Compliance, Clinical Research, Process Management, or related areas
Bachelor’s degree with 2–4 years of experience in Quality/Compliance within pharmaceutical, biotechnology, clinical research, or life sciences
Associate degree with 6+ years of relevant experience
High school diploma/GED with 8+ years of Quality/Compliance/Process Management experience
Preferred Experience:
Experience working with QMS systems, CAPA management, audit response tracking, or inspection readiness
Prior involvement in clinical research operations or GCP-regulated environments
Hands-on experience using AI tools, automation, or data-driven technologies for workflow optimization
Strong analytical, documentation, and communication skills
Key Responsibilities
Support R&D Quality (RDQ) Compliance Managers in operational quality activities.
Enter and track audit responses in the Quality Management System (QMS).
Input site inspection data into the Inspection Management System with high accuracy.
Work closely with deviation owners to ensure timely CAPA development, closure, and submission of objective evidence.
Ensure timely preparation of documents for the Potentially Reportable Serious Breach Committee.
Collaborate with Clinical Study Teams to support communication and information flow.
Prepare weekly quality metric reports for the General Medicine team (including deviations, CAPAs, serious breaches, audit and inspection findings).
Highlight overdue items and coordinate with RDQ Compliance Managers to ensure timely resolution.
Partner with Compliance Managers and data analytics teams to evaluate and optimize metric report effectiveness.
Facilitate General Medicine meetings, prepare agendas and presentations, track decisions, maintain action logs, and ensure follow-up.
Maintain General Medicine SharePoint and Microsoft Teams channels.
Support inspection readiness activities and provide quality oversight for small clinical programs.
Apply AI and digital tools to enhance process efficiency, automate workflows, and support data-driven decision-making.
Assist in developing lessons learned and best practices documentation.
Collaborate with cross-functional R&D Quality teams as required.
Core Skills and Competencies
Strong understanding of quality processes in GCP-regulated environments
Ability to manage multiple tasks with attention to detail
Strong communication, documentation, and analytical skills
Ability to work independently while supporting cross-functional teams
Familiarity with CAPA systems, QMS platforms, and audit tracking
Proficiency in MS Office, SharePoint, and digital collaboration tools
Ability to leverage AI tools for process improvement and operational efficiency
Why Join Amgen
Amgen offers a dynamic, ethical, and science-driven workplace that supports innovation, collaboration, and continuous learning. As part of this role, you can expect:
Competitive compensation and benefits
Opportunities for career development within a global biotechnology organization
A supportive culture emphasizing integrity, compliance, and scientific excellence
How to Apply
Interested applicants may apply through the official Amgen careers portal. Applications will remain open until a suitable candidate is selected.
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