Senior Specialist, Quality Risk & Governance

Qualifications

• 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

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.
• Maintain awareness of industry trends, regulatory updates, and emerging technologies related to Quality Risk Management and digital quality transformation.

Governance & Management Review

• 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.
• 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.