Manager, R&D Process Quality – Amgen | On-Site | Hyderabad, India
Location: Hyderabad, India
Category: Quality | R&D Process Quality
Work Type: On-Site
Experience Required: 7–15 years (based on qualification)
Job ID: R-229124
About Amgen
Amgen is a global biotechnology leader dedicated to discovering, developing, and delivering innovative medicines for some of the world’s most challenging diseases. With more than four decades of pioneering work in biotechnology, Amgen continues to leverage advanced science, technology, and human genetic insights to improve patient outcomes across the globe.
About the Role
Amgen is seeking a Manager, R&D Process Quality to join its R&D Quality – Business Intelligence and Data Analytics (BIDA) team. This role plays a critical part in ensuring quality and compliance across global R&D operations by developing data pipelines, dashboards, quality metrics, and analytics-driven insights that support key decision-making.
The position requires strong experience in R&D Quality within the pharmaceutical or biotechnology sector, paired with expertise in analytics, data interpretation, and compliance frameworks.
Key Responsibilities
As part of the global R&D Quality BIDA team, the Manager will be responsible for managing and enhancing analytics capabilities to ensure compliance with GxP requirements across clinical and research environments. Responsibilities include:
Data and Reporting
Extract, clean, and analyze data from internal systems for recurring and ad hoc reporting.
Build and maintain data pipelines to support operational and quality monitoring.
Generate, validate, and deliver KPIs, quality metrics, and performance indicators across the R&D Quality landscape.
Investigate data trends, inconsistencies, and operational insights for continuous improvement.
Dashboarding and Analytics
Design and maintain Tableau dashboards for compliance reporting and executive-level summaries.
Develop and maintain Python scripts for data processing, transformation, and automated reporting.
Create reusable analytics components and maintain technical documentation.
Ensure proper version control and structured workflow documentation.
Cross-Functional Collaboration
Partner with R&D Quality stakeholders to clarify data needs and ensure alignment on definitions and methodology.
Translate complex data outputs into clear, meaningful business insights.
Convert high-level business problems into actionable analytical solutions.
Support audits, inspections, CAPAs, and quality monitoring activities through data-driven reporting.
Required Qualifications & Experience
Education and Experience
Candidates must meet one of the following requirements:
Master’s Degree with 7–10 years of experience in Pharmaceutical or Biotechnology R&D Quality.
Bachelor’s Degree with 10–15 years of experience in Pharmaceutical or Biotechnology R&D Quality.
Essential Skills
Strong attention to detail and accuracy in data-driven deliverables.
Ability to work independently in a fast-paced, compliance-driven environment.
Proficiency in Tableau or similar visualization platforms.
Working knowledge of Python or another object-oriented programming language.
Familiarity with SQL and Databricks.
Proficiency in Microsoft Office applications and virtual collaboration platforms such as Teams.
Strong problem-solving, analytical thinking, and stakeholder communication skills.
Experience translating large datasets into actionable insights.
Preferred Skills
Experience with project management methodologies and tools.
Working knowledge of GCP, GLP, and GPvP regulations.
Familiarity with Databricks and SQL for advanced data analytics.
Experience collaborating with global, cross-functional, and multicultural teams.
Prior experience in biotech or pharmaceutical R&D environments.
Strong ability to balance independent work and team collaboration.
Soft Skills
Excellent written and verbal communication skills.
Professional demeanor with strong interpersonal and stakeholder engagement capabilities.
Adaptability and resilience when managing shifting priorities.
Collaborative mindset with the ability to build positive working relationships.
Discretion, integrity, and ability to perform effectively under pressure.
Equal Opportunity Statement
Amgen is an Equal Opportunity Employer. All qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
Amgen provides reasonable accommodation to applicants with disabilities for the application, interview process, and essential job functions. Candidates may request accommodation as needed.
Apply Now
Advance your career in global R&D Quality with a leading biotechnology organization committed to scientific excellence and patient impact.
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