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.
Gujarat :
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