Senior Specialist, Quality Risk & Governance

Amgen

Senior Specialist in Quality Risk & Governance at Amgen, focusing on Quality Risk Management and Governance processes to ensure regulatory compliance and operational excellence.

Posted 6/12/2026full-timeCalifornia, Massachusetts, North Carolina, Rhode Island • 🇺🇸 United StatesSenior💰 $132,037 - $178,639 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Support the development, execution, and continuous improvement of enterprise GxP Quality Risk Management programs and processes across multiple GxP domains (GMP, GCP, GLP, GVP, GDP, etc.).
Support implementation and continuous improvement of enterprise Quality Risk Management (QRM) frameworks aligned with global regulatory expectations.
Facilitate risk identification, assessment, mitigation, escalation, and monitoring activities across GxP functions and sites.
Partner with cross-functional stakeholders to identify emerging compliance and operational risks across the product lifecycle.
Support development and monitoring of Key Risk Indicators (KRIs), quality metrics, and risk dashboards to enable proactive decision-making.
Conduct risk trending, signal analysis, and data evaluation to identify systemic issues and opportunities for mitigation.
Assist with governance and oversight of enterprise risk registers, risk review forums, and escalation pathways.
Collaborate with Digital and Quality Systems teams to support risk management process integration within Veeva or other quality technology platforms.
Support inspection readiness activities and provide SME support during internal audits and regulatory inspections related to risk management processes.
Contribute to development of training materials and risk management capability-building initiatives across the organization.
Monitor industry trends, regulatory updates, and emerging technologies related to Quality Risk Management and digital quality transformation.
Support execution and continuous improvement of enterprise GxP Governance and Management Review processes.
Coordinate governance meetings, governance committee materials, metrics reporting, and follow-up actions.
Assist in maintaining governance frameworks, charters, roles/responsibilities, and escalation models.
Support preparation of executive-level governance reports and presentations summarizing quality risks, trends, compliance status, and key decisions.

Requirements

What you’ll need

Doctorate degree and 2 years of Quality, Operations, Manufacturing, Regulatory, Clinical, or related GxP experience in biotechnology, pharmaceutical, or regulated industry experience
Master’s degree and 4 years of Quality, Operations, Manufacturing, Regulatory, Clinical, or related GxP experience in biotechnology, pharmaceutical, or regulated industry experience
Bachelor’s degree and 6 years of Quality, Operations, Manufacturing, Regulatory, Clinical, or related GxP experience in biotechnology, pharmaceutical, or regulated industry experience
Associate’s degree and 10 years of Quality, Operations, Manufacturing, Regulatory, Clinical, or related GxP experience in biotechnology, pharmaceutical, or regulated industry experience
High school diploma / GED and 12 years of Quality, Operations, Manufacturing, Regulatory, Clinical, or related GxP experience in biotechnology, pharmaceutical, or regulated industry experience
Experience supporting GxP Quality Risk Management programs for Biologics and Devices/Combination Products.
Working knowledge of GxP regulations and risk management principles, including ICH Q9 and ISO 14971.
Experience leading and/or executing governance forums, management review processes, or quality councils.
Ability to develop executive-ready communications, presentations, and strategic narratives tailored to diverse audiences, including C-suite leadership, executive management, and operational teams.
Familiarity with quality systems and digital quality platforms such as Veeva.
Strong analytical skills with experience interpreting quality metrics, trends, and risk signals.
Experience working in cross-functional and matrixed organizations; ability to influence non-direct reporting groups / functions.
Ability to communicate complex quality or compliance topics clearly across organizational levels.
Strong organizational, facilitation, and project coordination skills.
Experience supporting inspections, audits, CAPA, or compliance initiatives.
Continuous improvement mindset with interest in innovation, digital transformation, and operational excellence.

Benefits

Comp & perks

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
group medical, dental and vision coverage
life and disability insurance
flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible.

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Hard Skills & Tools

GxP Quality Risk Managementrisk identificationrisk assessmentrisk mitigationKey Risk Indicators (KRIs)signal analysisdata evaluationgovernance frameworksquality metricscompliance initiatives

Soft Skills

analytical skillscommunication skillsorganizational skillsfacilitation skillsproject coordination skillsinfluencing skillspresentation skillsstrategic narrative developmentcollaboration skillscontinuous improvement mindset