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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 – Parel, Maharashtra, India

Location: Parel, Maharashtra, India
Job Category: Quality Compliance
Work Type: On-Site
Experience Required: See details below


About the Company

Amgen is a global biotechnology leader committed to advancing science and delivering transformative medicines that improve patient outcomes. For more than four decades, the organization has been at the forefront of biopharmaceutical innovation, integrating biology, technology, and human genetics to develop therapies for some of the world’s most challenging diseases.


Position Overview: Senior Associate, Quality Compliance

This role supports Amgen’s R&D Quality division, focusing specifically on Business Intelligence and Data Analytics (BIDA). The Senior Associate will contribute to strengthening data integrity, enhancing quality systems, and ensuring full compliance with GxP regulations. The position is responsible for maintaining data pipelines, supporting analytical tools, and delivering actionable insights that guide strategic decision-making across R&D Quality operations.


Key Responsibilities

  • Extract, clean, and process data from internal databases for ongoing and ad-hoc reporting.

  • Create, validate, and deliver KPIs, quality metrics, and performance dashboards across R&D Quality functions.

  • Analyze metric trends and investigate anomalies to support operational improvements.

  • Design, develop, and maintain Tableau dashboards for compliance reporting, oversight, and executive leadership reviews.

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

  • Develop reusable analytical components and maintain documentation for data workflows and version control.

  • Collaborate with global teams within R&D Quality and BIDA to ensure consistent quality and compliance throughout clinical and non-clinical operations.


Required Qualifications and Experience

Option 1:

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

Option 2:

  • 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.

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

  • Proficiency in Tableau or equivalent data visualization tools.

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

  • Experience with SQL and analytics platforms such as Databricks.

  • Strong command of Microsoft Office Suite (Excel, Word, PowerPoint, Outlook).

  • Effective communication, critical thinking, and problem-solving abilities.

  • Demonstrated experience in data analysis and translating outcomes into insights.


Preferred Skills

  • Experience with project management methodologies and tools.

  • Understanding of GCP, GLP, and GPvP requirements.

  • Familiarity with Databricks, SQL, and global project environments.

  • Background in biopharmaceutical or biotechnology research settings.

  • Ability to work independently and collaboratively across cross-functional teams.


Soft Skills

  • Excellent communication and documentation skills.

  • Professional demeanor and strong interpersonal capabilities.

  • Adaptability, resilience, and the ability to manage shifting priorities.

  • Strong collaboration skills and a commitment to maintaining high-quality standards.