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Sr. Associate, Quality Compliance

7-15 years
Not Disclosed
10 Nov. 19, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Associate, Quality Compliance – Hyderabad, India

Job ID: R-226914
Location: Hyderabad, India
Workplace Type: On-Site
Category: Quality
Date Posted: October 31, 2025
Company: Amgen


About Amgen

Amgen is a global biotechnology leader dedicated to advancing science and developing innovative medicines that address some of the world’s most challenging diseases. With more than 40 years of industry leadership, Amgen continues to combine biology, advanced analytics, and cutting-edge technology to deliver life-changing treatments to millions of patients worldwide.


Role Overview

Amgen is seeking a Senior Associate, Quality Compliance to join the R&D Quality – Business Intelligence and Data Analytics (BIDA) team. The position plays a key role in supporting data-driven decision-making, ensuring compliance with global regulatory standards, and maintaining high-quality operations across R&D clinical programs.

This role supports the development, maintenance, and optimization of data pipelines, dashboards, and reporting frameworks that underpin Amgen’s quality compliance functions.


Key Responsibilities

Data Management & Reporting

  • Extract and clean data from internal systems for planned and ad hoc reporting.

  • Develop and maintain data pipelines supporting quality and compliance activities.

  • Generate, validate, and deliver KPIs, quality metrics, and performance indicators.

Analytics & Insights

  • Analyze trends, anomalies, and operational issues to identify actionable insights.

  • Translate large datasets into meaningful quality summaries and operational signals.

Dashboarding & Automation

  • Design and maintain Tableau dashboards for monitoring, compliance reporting, and leadership reviews.

  • Develop and maintain Python scripts for data processing, transformation, and reporting automation.

  • Create reusable analytical components and ensure proper documentation.

Documentation & Version Control

  • Maintain accurate documentation of scripts, data workflows, and analytical processes.

  • Ensure robust version control practices for reproducibility and compliance.


Required Qualifications & Experience

Education & Experience

  • Master’s degree with 7–10 years of experience in Pharmaceutical or Biotechnology R&D Quality
    OR

  • Bachelor’s degree with 10–15 years of experience in Pharmaceutical or Biotechnology R&D Quality.


Must-Have Skills

  • Strong attention to detail and accuracy in all deliverables.

  • Ability to operate independently in a fast-paced environment.

  • Proficiency in Tableau or equivalent visualization platforms.

  • Working knowledge of Python or object-oriented programming languages.

  • Familiarity with SQL and Databricks.

  • Proficiency in Microsoft Office Suite and virtual collaboration tools (Teams).

  • Strong analytical, critical-thinking, and problem-solving capabilities.

  • Experience converting complex datasets into clear, actionable insights.


Preferred Skills

  • Knowledge of GCP, GLP, and GPvP compliance frameworks.

  • Familiarity with project management methodologies and tools.

  • Experience working with multinational, cross-functional teams.

  • Background in biotech or pharmaceutical research operations.

  • Ability to work both independently and collaboratively.


Soft Skills

  • Excellent written and verbal communication skills.

  • Strong professionalism and interpersonal abilities.

  • Adaptability to changing priorities and dynamic environments.

  • Positive, collaborative mindset with strong relationship-building skills.

  • Resilience and ability to perform well under pressure.