Manager, R&D Process Quality

7-15 years

Not Disclosed

Hyderabad

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

Manager, R&D Process Quality (Quality Compliance) – Hyderabad, India

Job ID: R-229124
Location: Hyderabad, India
Work Type: On-Site
Category: Quality
Date Posted: October 31, 2025
Company: Amgen

About Amgen

Amgen is a global biotechnology leader dedicated to discovering, developing, manufacturing, and delivering innovative medicines that address the world’s most challenging diseases. With more than four decades of scientific leadership, Amgen continues to advance cutting-edge therapies using advanced technologies and human genetic insights. The company’s mission is to improve and extend the lives of millions of patients worldwide.

Position Overview

Amgen is seeking a Manager, R&D Process Quality (Quality Compliance) to join its R&D Quality – Business Intelligence and Data Analytics (BIDA) team. The role is responsible for delivering high-quality data insights, expanding analytics capabilities, and supporting global quality compliance functions across R&D operations. This position is critical in maintaining data integrity, regulatory compliance, and high operational standards throughout clinical development activities.

Key Responsibilities

Data Management & Reporting

Extract, clean, and manage data from internal systems for routine and ad hoc reporting.
Build and maintain robust data pipelines to support operational and compliance reporting.
Generate, validate, and distribute KPIs, quality metrics, and performance indicators across R&D Quality teams.

Analytics & Insights

Analyze metric trends, deviations, and operational signals to provide actionable insights.
Translate complex datasets into clear, business-ready narratives for leadership.
Convert high-level business questions into structured analytical problems.

Visualization & Automation

Design, develop, and maintain Tableau dashboards for monitoring, governance, and executive reporting.
Develop and maintain Python-based scripts for data extraction, transformation, and automation.
Create reusable analytical components and ensure proper documentation and version control.

Cross-Functional Collaboration

Work closely with global stakeholders to align on data definitions and reporting needs.
Support quality audits, inspections, CAPA tracking, and recurring metrics production.
Deliver well-structured, data-driven reports for senior leadership and cross-functional teams.

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 Functional Skills

Strong attention to detail and accuracy in data deliverables.
Ability to operate independently in a fast-paced, dynamic environment.
Proficiency in Tableau or similar data visualization platforms.
Working knowledge of Python, object-oriented programming, and basic SQL.
Experience using Databricks, or willingness to learn.
Strong command of Microsoft Office tools and virtual collaboration platforms such as MS Teams.
Demonstrated capability in data analysis and converting datasets into actionable insights.
Strong communication, critical thinking, and problem-solving skills.

Preferred Skills (Good-to-Have)

Understanding of GCP, GLP, and/or GPvP quality frameworks.
Experience with project management methodologies and tools.
Prior work experience within multinational, cross-functional environments.
Background in biotech/pharmaceutical research operations.
Strong independent work ethic combined with effective teamwork capabilities.

Soft Skills

Excellent written and verbal communication skills.
High professionalism with strong interpersonal abilities.
Adaptability in rapidly changing environments.
Collaborative mindset with the ability to build strong cross-functional relationships.
Strong analytical thinking, resilience, and discretion.

Equal Opportunity Statement

Amgen is an Equal Opportunity Employer and welcomes applicants regardless of race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. The company provides reasonable accommodation for applicants with disabilities throughout the hiring process.

Apply Now

Advance your career with a global biotechnology leader committed to scientific innovation and patient impact.
Submit your application today at thepharmadaily.com.

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Manager, R&D Process Quality

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