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Senior Associate – Quality Compliance

7-15 years
Not Disclosed
10 Nov. 24, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ 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 (On-Site)

Location: Hyderabad, India**

Experience Required:
Master’s Degree with 7–10 years of experience in Pharma/Biotechnology R&D Quality
OR
Bachelor’s Degree with 10–15 years of experience in Pharma/Biotechnology R&D Quality


About the Company

Amgen is a global biotechnology leader dedicated to discovering, developing, manufacturing and delivering innovative medicines that improve and extend lives. With more than four decades at the forefront of biotechnology, Amgen continues to advance science by integrating cutting-edge technology and human genetic data to address the world’s toughest health challenges.


About the Role: Senior Associate, Quality Compliance

This role sits within the R&D Quality – Business Intelligence and Data Analytics (BIDA) Team, supporting the delivery of high-value insights, data pipelines, and reporting solutions. The Senior Associate will drive compliance and quality excellence across R&D operations by managing data workflows, building analytical dashboards, and ensuring adherence to global regulatory standards.

This position is on-site in Hyderabad, India.


Key Responsibilities

  • Extract, clean, and validate data from internal systems for routine and ad-hoc reporting.

  • Build, maintain, and optimize data pipelines and workflow documentation.

  • Generate KPIs, quality metrics, and performance indicators across R&D Quality functions.

  • Analyze data trends, detect anomalies, and deliver actionable insights.

  • Design and develop Tableau dashboards for compliance reporting and operational performance.

  • Create and manage Python-based scripts for data processing and automation.

  • Support development of reusable data analysis components and version-controlled script libraries.

  • Collaborate with global R&D Quality stakeholders to ensure adherence to GxP regulations and quality standards.


Required Skills & Competencies (Must-Have)

  • Strong attention to detail, accuracy, and analytical rigor.

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

  • Proficiency with Tableau or equivalent data visualization platforms.

  • Working knowledge of Python, object-oriented programming concepts, SQL, and Databricks.

  • Proficiency with Microsoft Office Suite and virtual collaboration tools (Teams, etc.).

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

  • Demonstrated expertise in transforming data into actionable insights.


Preferred Skills (Good-to-Have)

  • Experience with project management tools and methodologies.

  • Understanding of GCP, GLP, GPvP and other regulatory frameworks.

  • Experience working with multinational teams in a global setting.

  • Background in biotechnology or pharmaceutical research environments.

  • Ability to work both independently and collaboratively across diverse teams.


Soft Skills

  • Excellent verbal and written communication skills.

  • Strong interpersonal and stakeholder management capabilities.

  • Adaptability to evolving priorities and operational needs.

  • High professionalism, discretion, and resilience under pressure.

  • Collaborative mindset and the ability to build effective working relationships.


Work Location

Type: On-Site
City: Hyderabad, India
Category: Quality
Job ID: R-225626