Quality Compliance Manager – Hyderabad, India
Employer
Amgen
Location
Hyderabad, India – On-site
Category
Quality
Job Overview
Amgen is seeking a Quality Compliance Manager within the General Medicine & Obesity Therapeutic Area to provide end-to-end quality oversight for clinical development programs. This role ensures regulatory compliance, audit readiness, and continuous improvement of quality processes across global and local clinical trials. Reporting to the Quality Compliance Associate Director, you will support study teams, trial sites, and vendors while driving risk-based quality assurance strategies in alignment with Quality by Design principles.
Key Responsibilities
Serve as a GCP Subject Matter Expert, providing independent quality advice across clinical trial activities.
Oversee quality management for all stages of clinical development, ensuring adherence to risk-based quality principles.
Implement and monitor the Risk Assessment Categorization Tool (RACT) to identify and mitigate risks to critical data, processes, and patient safety.
Support regional compliance expertise and ensure adherence to local regulations.
Collaborate with Clinical Trial Teams on deviations, CAPAs, inspection readiness, and serious breaches.
Ensure data integrity and compliance with technologies for data collection, including biomarkers and imaging methods.
Review clinical trial protocols for simplification, lessons learned, and critical data identification.
Implement innovative quality oversight methodologies using AI, NLP, and advanced analytics.
Manage responses to regulatory inspections, audit findings, and self-reported deviations.
Conduct risk-based GCP audits for investigator sites, affiliates, and study-level operations.
Provide study-specific vendor quality oversight.
Prepare and communicate quality metrics and trends to senior management.
Required Qualifications
Education & Experience
Doctorate degree OR
Master’s degree with 2 years of quality management experience OR
Bachelor’s degree with 4 years of quality management experience OR
Associate’s degree with 8 years of quality management experience OR
High school diploma/GED with 10 years of quality management experience
Preferred Qualifications
Experience in Quality Management/Quality Assurance within pharmaceutical or biotech industries.
Expertise in risk-based quality, Quality by Design, and QMS management (electronic QMS like Veeva or TrackWise).
Strong knowledge of clinical R&D operations, regulatory submissions, and inspection management.
Quality oversight experience in clinical trials, protocol development, and submissions.
Excellent verbal and written communication skills, with strong analytical and critical-thinking abilities.
Ability to translate feedback into efficient quality processes and articulate technical concepts clearly.
What Amgen Offers
Competitive salary and total rewards package, including discretionary bonuses and stock-based incentives.
Comprehensive benefits covering health, dental, vision, life insurance, and retirement plans.
Flexible work models including on-site, remote, or hybrid arrangements where feasible.
Opportunities for career growth, professional development, and high-impact projects.
Award-winning time-off plans and supportive workplace culture.
How to Apply
Interested candidates may submit applications through Amgen Careers. Amgen is an Equal Opportunity Employer, committed to inclusive hiring and providing reasonable accommodations for individuals with disabilities.
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