Instagram
youtube
Facebook

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-225626
Location: Hyderabad, India
Workplace Type: On-Site
Category: Quality
Date Posted: October 31, 2025


About Amgen

Amgen is a global biotechnology leader committed to advancing science and developing innovative therapies for serious diseases. For more than four decades, the company has shaped the biotechnology landscape through its focus on biologics, advanced technology, and human genetic insights. Amgen continues to deliver life-changing medicines to millions of patients worldwide.


Position Overview

Amgen is seeking a Senior Associate, Quality Compliance to join the R&D Quality – Business Intelligence and Data Analytics (BIDA) team. The position supports quality oversight, compliance reporting, and data-driven decision-making across global R&D operations. The role ensures that Amgen’s research and development activities maintain the highest standards of GxP compliance and operational quality.


Key Responsibilities

Data Extraction & Pipeline Management

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

  • Build, maintain, and enhance data pipelines supporting R&D Quality processes.

Quality Metrics & Compliance Reporting

  • Generate and validate KPIs, quality metrics, and operational indicators.

  • Analyze trends, deviations, and compliance-related insights for decision-making.

Dashboard Development & Automation

  • Design, develop, and maintain Tableau dashboards for compliance monitoring and executive reviews.

  • Develop and optimize Python scripts for data transformation, automation, and reporting workflows.

  • Contribute to reusable code components, templates, and documentation.

Documentation & Version Control

  • Maintain proper documentation for all scripts, workflows, and analytical methods.

  • Ensure strong version control practices to support audit readiness and reproducibility.


Qualifications and Experience

Education & Experience Requirements

  • 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 with high accuracy in deliverables.

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

  • Proficiency with Tableau or other visualization platforms.

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

  • Familiarity with SQL, Databricks, and data engineering fundamentals.

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

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

  • Experience interpreting large datasets and converting them into actionable insights.


Good-to-Have Skills

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

  • Experience with project management methodologies.

  • Prior experience working in global, cross-functional teams.

  • Background in biotech or pharmaceutical research environments.

  • Strong independent working capabilities and collaboration skills.


Soft Skills

  • Excellent written and verbal communication.

  • High-level professionalism and strong interpersonal skills.

  • Ability to manage shifting priorities and complex tasks.

  • Collaborative mindset with the ability to build strong working relationships.

  • Resilience and discretion, with the ability to perform effectively under pressure.