Manager, R&D Process Quality

Manager, Quality Compliance

Role Name: Manager, Quality Compliance

Department Name: R&D Quality

Role GCF: 5

ABOUT AMGEN

Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.

ABOUT THE ROLE

Role Description:

The manager will work within R&D Quality's Business Intelligence and Data Analytics (BIDA) team to help deliver actionable information and recommendations to key leaders and stakeholders by maintaining and expanding our data pipelines, tools, reporting, and data communication strategies. This role contributes to ensuring Amgen's pursuit of life-saving medication is done with the highest regard for quality and compliance to regulations.

Roles & Responsibilities:

As an integral team member working globally with BIDA, other R&D Quality team members, and R&D Quality stakeholders to ensure quality across our trials and compliance with GxP regulations and other requirements:

• Extract and clean data from internal systems for regular and ad hoc reporting, including data pipeline creation and maintenance
• Generate, validate, and deliver KPIs, quality metrics, and performance indicators used across the R&D Quality landscape
• Investigate and analyze metric trends, anomalies, and operational insights
• Design, build, and maintain Tableau dashboards for operational monitoring, compliance reporting, and executive summaries
• Develop and maintain Python scripts used for data processing, transformation, and report automation
• Help create reusable components for common data analysis tasks and documentation
• Ensure version control and proper documentation of scripts and workflows
• Collaborate with stakeholders to clarify data needs, ensure alignment on definitions, and deliver fit-for-purpose outputs
• Create polished, data-driven reports for senior leadership and cross-functional teams.
• Translate complex data outputs into meaningful business insights and narratives
• Translate high-level business questions into analytic problems and guide the team toward actionable outputs.
• Coordinate ad hoc analyses and recurring metrics production for quality audits, inspections, CAPAs, and KPIs.

Basic Qualifications and Experience:

• Master's degree and 7-10 years in Pharma and Biotechnology R&D Quality OR
• Bachelor's degree and 10-15 years of years in Pharma and Biotechnology R&D Quality.

Functional Skills:

Must-Have Skills:

• Exceptional attention to detail and accuracy in all deliverables.
• Ability to work independently and proactively in a fast-paced environment.
• Proficiency with Tableau or similar data visualization tools
• Familiarity with Python or other object-oriented programming language
• Familiarity with SQL and Databricks
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and virtual collaboration tools (e.g., Teams)
• Effective communication, critical thinking and problem-solving
• Experience in conducting data analyses and translating data sets into actionable insights

Good-to-Have Skills:

• Familiarity with project management tools and methodologies
• Knowledge of GCP, GLP and/or GPvP
• Familiarity with Databricks and SQL
• Experience working in a multinational environment with global teams.
• Experience within Biotech/pharmaceutical Research
• Independent and teamwork capabilities

Soft Skills:

• Excellent verbal and written communication skills
• High degree of professionalism and interpersonal skills
• Strong problem-solving abilities and adaptability to changing priorities
• Collaborative mindset and ability to build positive relationships across diverse teams
• Resilience, discretion, and the ability to thrive under pressure

EQUAL OPPORTUNITY STATEMENT

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.