Senior Associate, R&D Quality Compliance – Hyderabad, India
Job ID: R-225413
Category: Quality
Work Location: On-Site
About the Role
Amgen is seeking a Senior Associate, Research and Development (R&D) Quality Compliance to support Quality Compliance Managers in strengthening oversight processes, maintaining high-quality standards and ensuring alignment with global regulatory expectations. This role is essential to the efficiency and compliance of Amgen’s R&D Quality systems, with a strong focus on data accuracy, process governance and continuous improvement.
The position contributes directly to quality operations across clinical programs and requires strong analytical skills, attention to detail and proficiency in quality documentation and reporting.
Key Responsibilities
Enter audit responses into the Quality Management System (QMS) and ensure accuracy and completeness.
Upload and maintain site inspection data within the Inspection Management System.
Collaborate with deviation owners to support timely CAPA development, evidence submission and closure within established timelines.
Assist with documentation preparation for the Potentially Reportable Serious Breach Committee.
Work closely with Clinical Study Teams, as directed by R&D Quality Compliance Managers, to ensure clear communication and timely coordination.
Prepare weekly metric reports for the General Medicine team, including status of deviations, CAPAs, serious breaches and audit/inspection findings; highlight overdue activities and track closure progress.
Partner with data quality analytics teams to evaluate and enhance the effectiveness of quality metric reporting.
Facilitate General Medicine team meetings, including agenda creation, presentation development, action tracking and follow-up.
Maintain tracking logs, including Decision & Action logs and Q&A records, ensuring all items are addressed.
Support inspection readiness activities under the supervision of Quality Compliance Managers.
Provide quality oversight for small clinical programs in alignment with compliance standards.
Utilize artificial intelligence (AI) tools to optimize workflows, automate routine tasks and support data-driven quality improvements.
Support the creation of lessons-learned documentation and best-practice guidance.
Collaborate with broader R&D Quality teams to ensure harmonized quality processes.
Maintain the General Medicine SharePoint site and Teams channels to ensure up-to-date documentation and communication.
Required Experience & Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology or a related discipline.
2–4 years of experience in Quality Compliance, Quality Assurance, Clinical Research, R&D Quality or related functions within the pharmaceutical or biotechnology industry.
Strong understanding of QMS processes, deviation management, CAPA systems and documentation workflows.
Experience preparing quality metrics, dashboards or reports for leadership review.
Proficiency in MS Office, SharePoint and collaboration tools such as Teams.
Ability to interpret quality data, identify risks and support mitigation activities.
Demonstrated capability to apply AI tools to streamline processes and support decision-making.
Strong communication, organizational and problem-solving skills.
Preferred Qualifications
Experience supporting clinical audits, inspections or inspection readiness activities.
Familiarity with global regulatory requirements, GCP guidelines and R&D quality operations.
Prior involvement in cross-functional quality improvement initiatives.
Experience with analytics tools for metrics optimization and trend analysis.
Why Join Amgen?
Amgen offers a collaborative, science-focused work environment where your contributions directly support global clinical research and patient-impact initiatives. Employees benefit from robust learning opportunities, competitive compensation packages and a culture built on integrity, innovation and quality.
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