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,fullerand longer. We discover, develop,manufactureand deliver innovative medicines to help millions of patients. Amgen helpedestablishthe biotechnology industry more than 40 years ago andremainson thecutting-edgeof innovation, using technology and human genetic data to push beyondwhat’sknown today.

ABOUT THE ROLE

Role Description:

Themanagerwill workwithinR&D Quality’sBusiness Intelligence and Data Analytics(BIDA)team tohelpdeliver actionable informationand recommendationsto key leaders and stakeholdersbymaintainingand expanding our data pipelines, tools, reporting, and data communication strategies.This role contributes to ensuring Amgen’s pursuit of life-saving medicationis done with the highest regard for quality and compliance to regulations. 

Roles & Responsibilities:

As an integral team member working globally withBIDA, otherR&D Quality team members, andR&D Quality stakeholdersto ensurequality across ourtrialsandcompliance withGxPregulations 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, andmaintainTableau dashboards for operational monitoring, compliance reporting, and executive summaries

• Develop andmaintainPython 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 recurringmetricsproduction for quality audits, inspections, CAPAs, and KPIs.

Basic Qualifications and Experience:

• Master’s degree and7-10yearsin Pharma and Biotechnology R&D QualityOR

• Bachelor’s degree and10-15years ofyears 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.

• Proficiencywith Tableauor similar data visualization tools

• Proficiencywith Python or other object-oriented programming language

• Proficiencywith SQL and Databricks

• ProficiencyinMicrosoft Office Suite (Word, Excel, PowerPoint, Outlook) and virtual collaboration tools (e.g., Teams)

• Effective communication, criticalthinkingand 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 ofGCP, GLP,GPvP, and/or the conduct of clinical trials 

• Experience working in a multinational environment with global teams.

• Experience within Biotech/pharmaceutical Research 

• Independent andteamworkcapabilities

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 toparticipatein the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to requestan accommodation.