Amgen Hiring Quality Compliance Manager in Hyderabad

Amgen, a global leader in biotechnology, is seeking a qualified professional for the position of Quality Compliance Manager in Hyderabad. This vital role involves providing proactive, risk-based quality support for the entire clinical development program, ensuring compliance with Good Clinical Practice (GCP) and global regulations.

Key Job Responsibilities

Reporting to the Quality Compliance Associate Director, the manager will oversee quality management and ensure compliance for global and local clinical trials.

GCP Subject Matter Expert: Provide independent quality advice for clinical trial activities, aligning with current best practices.
Risk Management: Oversee the Risk Assessment Categorization Tool (RACT) for trials to ensure proper identification, prioritization, and mitigation of risks to patient safety and data integrity.
Quality Oversight: Provide quality oversight for all stages of clinical development, including protocol review for simplification and identification of critical data/processes.
Quality Management Systems: Support Clinical Trial Teams with Deviations/CAPAs, Inspection Readiness and Management, and Serious Breaches/Privacy Issues.
Data Analysis & Improvement: Prepare, analyze, and identify data quality indicators/trends, recommend and implement corrective actions, and communicate quality metrics to key partners.
Audits & Inspections: Manage/support regulatory inspection and review responses. Plan, conduct, and report out on risk-based GCP audits (investigator site, affiliate, and study level).
Innovation: Actively seek and implement innovative quality oversight methodologies, such as risk-methods leveraging AI and Natural Language Processing.

Candidate Profile and Qualifications

Category	Requirement
Minimum Education & Experience	* Doctorate degree OR * Master’s degree and 2 years of quality management experience OR * Bachelor’s degree and 4 years of quality management experience OR * Associate’s degree and 8 years of quality management experience OR * High school diploma / GED and 10 years of quality management experience.
Total Experience	2–8 years in relevant areas.
Core Experience	Experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and Quality by Design are core responsibilities.
Technical Skills	* Oversight and implementation of Quality Management Systems (QMS) and experience managing quality in electronic QMS (Veeva or TrackWise). * Thorough understanding of Clinical R&D activities and Global Regulations. * Knowledge of Regulatory Submission and Inspection Management procedures.
Soft Skills	Excellent verbal and written communication, strong analytical, critical-thinking, and decision-making abilities.