GCP Quality Compliance Manager – Hyderabad, India
Job ID: R-224380
Category: Quality
Work Location: On-Site
About the Role
Amgen is seeking a GCP Quality Compliance Manager to support and enhance the Quality Management System (QMS) across Research and Development operations. This role is pivotal in ensuring adherence to Good Clinical Practice (GCP), global regulatory expectations and quality standards while contributing to continuous improvement within Amgen’s R&D quality framework.
As part of Amgen’s mission-driven organization, you will help advance innovative science and support patient-centric initiatives across global clinical development programs.
Key Responsibilities
Support the maintenance, enhancement and implementation of the R&D Quality Management System (QMS).
Track, document and monitor quality initiatives to ensure compliance with regulatory, procedural and operational standards.
Contribute to the collection, analysis and reporting of quality metrics, including KPIs and KQIs, to identify risks, patterns and improvement opportunities.
Provide direct support to the Senior Manager in overseeing GCP compliance across R&D functions.
Serve as a liaison between Process Quality and Global Networks to ensure seamless information flow.
Support the management and oversight of the Serious Breach Process.
Conduct risk assessments for processes, vendors and functional units.
Identify data quality gaps, analyze root causes and implement corrective and preventive actions.
Coordinate end-to-end activities related to inspections and audits, including preparation, execution, close-out and response development.
Utilize knowledge of SOP governance and standards management to enhance overall quality oversight.
Apply project management methodologies to support quality initiatives and cross-functional deliverables.
Integrate market trends, data insights and regulatory expectations into quality planning and recommendations.
Demonstrate strong critical thinking skills to distinguish high-risk issues from routine operational gaps.
Support innovation by exploring advanced quality oversight methodologies including AI-driven risk management and data analytics.
Key Capabilities
Strong understanding of SOP and standards management in complex R&D environments.
Ability to analyze technical information and deliver accurate, structured interpretations.
Advanced business insight and subject matter expertise within GCP and Quality Compliance.
Proficiency in root cause analysis and corrective/preventive action (CAPA) management.
Excellent communication skills and ability to collaborate across global functions.
Strategic, analytical, and detail-oriented approach to quality risk identification and mitigation.
Proven capability to manage data, metrics and reporting with precision.
Required Qualifications (Experience & Education)
Candidates must meet one of the following minimum qualifications:
Doctorate degree, or
Master’s degree with 2+ years of experience in Quality, Compliance or Process Management, or
Bachelor’s degree with 4+ years of experience in Quality, Compliance or Process Management, or
Associate degree with 8+ years of relevant experience, or
High school diploma/GED with 10+ years of experience in Quality, Compliance or Process Management.
Preferred Qualifications
2+ years of hands-on experience in Quality Management, Quality Assurance or related domains within the pharmaceutical or biotech sector.
Strong understanding of Clinical R&D activities and global regulatory guidelines.
Proven analytical, critical thinking and decision-making skills.
Experience with process monitoring, data analytics and modern quality oversight tools.
Demonstrated ability to manage multiple priorities and work collaboratively in a fast-paced environment.
Excellent verbal and written communication skills with strong business writing proficiency.
Ability to interpret, articulate and communicate technical concepts accurately.
Why Join Amgen?
Amgen offers a collaborative, science-driven environment focused on innovation, patient impact and continuous learning. Employees benefit from strong career growth opportunities, competitive compensation, comprehensive benefits and flexible work models where applicable.
You will be part of a global organization that values diversity, integrity and scientific excellence while contributing to one of the world’s most respected biotechnology companies.
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