Quality Compliance Manager Job at Amgen (Hyderabad)

Quality Compliance Manager

Amgen

Location:
India , Hyderabad

Category:
Quality Control

Contract Type:
Not provided

Salary:

Not provided

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Job Description:

We are hiring a Quality Compliance Manager, which will operate within the General Medicine & Obesity Quality Therapeutic Area. In this vital role you will provide proactive end to end quality support for the development and implementation of a risk-based quality assurance strategy that advances quality by design principles for the full clinical development program. (protocol development, database lock, and regulatory submissions/ approvals). Reporting to the Quality Compliance Associate Director, you will oversee quality management and ensure compliance for global and local clinical trials by supporting study teams and trial sites involved in Amgen-sponsored Trials.

Job Responsibility:

Provide proactive end to end quality support for the development and implementation of a risk-based quality assurance strategy
Provide independent and objective quality advice in support of clinical trial activities
Provide quality oversight for Amgen programs for all stages of products in clinical development
Ensure quality oversight for the Risk Assessment Categorization Tool (RACT) for each trial
Support the establishment of regional expertise to ensure quality and compliance to local Regulations
Support Clinical Trial Teams for all quality management activities
Ensure TA-specific data integrity
Review clinical trial protocols
Actively seek and implement innovative and proactive quality oversight methodologies
Manage/support regulatory inspection and review responses
Prepare, analyze and Identify data quality indicators/trends
Support Monthly meetings with program level CPO senior management/associate directors
Support response generation for audit findings and self reported deviations
Provide Study Specific Vendor Quality Oversight
Plan, conduct and report out on risk-based Good Clinical Practices (GCP) audits

Requirements:

Doctorate degree
Master’s degree and 2 years of quality management experience
Bachelor’s degree and 4 years of quality management experience
Associate’s degree and 8 years of quality management experience
High school diploma / GED and 10 years of quality management 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 a core responsibility
Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise
Thorough understanding of Clinical R&D activities and Global Regulations
Knowledge of the Regulatory Submission and Inspection Management procedures
Quality Oversight of Clinical Trials, including clinical trial protocol development, execution, and submissions
Excellent verbal and written communication skills, including strong business writing abilities and active listening
Ability to transform business and team member feedback into clear, efficient processes using a straightforward language and format
Strong analytical, critical-thinking, and decision-making abilities
Capability to understand and articulate technical concepts and literature in spoken and written English

Nice to have:

Experience in Quality Management, Quality Assurance or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility
Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise
Thorough understanding of Clinical R&D activities and Global Regulations
Knowledge of the Regulatory Submission and Inspection Management procedures
Quality Oversight of Clinical Trials, including clinical trial protocol development, execution, and submissions
Excellent verbal and written communication skills, including strong business writing abilities and active listening
Ability to transform business and team member feedback into clear, efficient processes using a straightforward language and format
Strong analytical, critical-thinking, and decision-making abilities
Capability to understand and articulate technical concepts and literature in spoken and written English

What we offer:

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible

Additional Information:

Job Posted:
January 06, 2026

Employment Type:

Fulltime

Work Type:

On-site work

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