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Jobs · Finance · California

Senior Specialist, Quality Risk & Governance

BioSpace · Thousand Oaks, CA · 3 wk ago
FinanceFull-time

About the role

The Senior Specialist, Quality Risk & Governance role at Amgen combines a strong emphasis on Quality Risk Management with strategic and operational support for GxP Governance. This role helps strengthen and evolve the enterprise GxP Quality Management System through proactive risk management and effective governance practices.

Responsibilities

  • 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.

  • Aid in 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.

  • Help ensure alignment between governance processes, enterprise quality objectives, and operational strategies.

  • Collaborate with stakeholders to improve visibility and integration of risks, KPIs, regulatory intelligence, and continuous improvement initiatives across governance structures.

  • Support process harmonization and standardization initiatives across sites and functions.

  • Participate in continuous improvement efforts supporting the GxP Quality Operating Model and enterprise transformation initiatives.

  • Contribute to benchmarking activities and adoption of industry best practices related to governance and management review.

Requirements

  • Doctorate degree and 2 years of Quality, Operations, Manufacturing, Regulatory, Clinical, or related GxP experience in biotechnology, pharmaceutical, or regulated industry experience OR

  • Masters degree and 4 years of Quality, Operations, Manufacturing, Regulatory, Clinical, or related GxP experience in biotechnology, pharmaceutical, or regulated industry experience OR

  • Bachelors degree and 6 years of Quality, Operations, Manufacturing, Regulatory, Clinical, or related GxP experience in biotechnology, pharmaceutical, or regulated industry experience OR

  • Associates degree and 10 years of Quality, Operations, Manufacturing, Regulatory, Clinical, or related GxP experience in biotechnology, pharmaceutical, or regulated industry experience OR

  • High school diploma / GED and 12 years of Quality, Operations, Manufacturing, Regulatory, Clinical, or related GxP experience in biotechnology, pharmaceutical, or regulated industry experience

Preferred Qualifications

  • 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.

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