GCP Quality Compliance Manager – Amgen | Hyderabad, India
Category: Quality
Work Model: On-site
Job ID: R-224380
Posted: October 31, 2025
Overview
Amgen is a global biotechnology leader committed to transforming the lives of patients worldwide. With a strong legacy in advancing innovative therapies across Oncology, Inflammation, General Medicine, and Rare Diseases, Amgen continues to strengthen its research and development capabilities.
The company is now seeking a GCP Quality Compliance Manager to support its R&D Quality Management System (QMS) and uphold the highest standards of Good Clinical Practice (GCP). This position is based in Hyderabad, India, offering an opportunity to contribute to a world-class quality function within a highly regulated, science-driven environment.
Experience Required
Doctorate degree OR
Master’s degree with 2+ years in Quality, Compliance, or Process Management OR
Bachelor’s degree with 4+ years in Quality, Compliance, or Process Management OR
Associate degree with 8+ years in relevant quality/compliance areas OR
High school diploma/GED with 10+ years in Quality/Compliance/Process Management
Preferred: Minimum 2 years of experience in Quality Management, Quality Assurance, or related functions within pharma/biotech, including strong exposure to risk-based quality management and QMS processes.
Role Summary
As the GCP Quality Compliance Manager, you will play a critical role in supporting Amgen’s R&D Quality organization. You will help implement, monitor, and enhance quality systems, ensure GCP compliance across global functions, and contribute to quality oversight activities that enable safe, efficient, and compliant clinical research.
Key Responsibilities
Support the maintenance and continuous improvement of Amgen’s R&D Quality Management System.
Assist in tracking, documenting, and implementing quality initiatives aligned with regulatory expectations.
Collect, analyze, and report quality metrics (KPIs, KQIs) to identify trends, gaps, and improvement opportunities.
Provide operational support to the Senior Manager in ensuring GCP compliance across R&D functions.
Act as a liaison between Process Quality teams and Global Networks to facilitate consistent communication and alignment.
Support the Serious Breach Process and contribute to risk assessments for processes, vendors, and internal functions.
Identify data quality trends, recommend corrective actions, and ensure timely follow-up.
Coordinate inspection and audit activities, including preparation, execution, and documentation.
Utilize quality oversight methodologies leveraging AI, NLP, and advanced analytics to enhance monitoring.
Key Skills and Capabilities
Strong understanding of SOP and standards management across R&D environments.
Ability to communicate effectively with cross-functional teams.
Strong analytical and critical-thinking skills with attention to detail.
Ability to differentiate critical issues from non-critical issues.
Experience in risk-based quality methodologies and root-cause analysis.
Strong capability in data management, reporting, and quality signal detection.
Ability to interpret technical content and communicate it clearly in English.
Familiarity with global clinical regulations and GCP requirements.
Effective project management and organizational skills.
Preferred Qualifications
Experience in pharmaceutical or biotechnology quality functions with focus on GCP.
Understanding of Clinical R&D processes and regulatory frameworks.
Proven ability to apply analytical approaches and modern data technologies for process monitoring.
Strong communication and business writing skills.
Track record of collaborating in high-performance teams and supporting decision-making.
What You Can Expect from Amgen
Amgen provides a comprehensive Total Rewards program designed to support both personal and professional growth. Benefits may include:
Competitive compensation packages
Comprehensive health and welfare plans
Retirement and savings plans with company contributions
Performance-based bonuses
Long-term stock incentives
Flexible working models (where applicable)
Generous time-off programs
Opportunities for career development and continuous learning
About Amgen
Founded in 1980, Amgen is one of the world’s leading biotechnology companies, driven by a mission to serve patients with serious illnesses. The organization fosters a culture built on collaboration, innovation, integrity, and scientific excellence. Amgen is committed to diversity and equal opportunity, ensuring all qualified candidates are considered without regard to legally protected characteristics.
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