Senior Specialist, Quality Risk & Governance

Role Overview

• 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

• 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.

Tech Stack

• Google Cloud Platform

Benefits

• 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.