Associate Director, Global GxP Governance, Risk & Intelligence

Job Description

GENERAL POSITION SUMMARY:

The Associate Director, Global GxP Governance, Risk & Intelligence is responsible for leading the Global GxP Governance, Risk Management and Knowledge Management programs to strengthen proactive quality oversight across the organization.

This role drives the integration of risk intelligence, data insights, and organizational knowledge to enable informed decision-making, regulatory compliance, and continuous improvement across the global Vertex Quality Management system (QMS).

The Associate Director acts as the global process owner for GxP Governance, Risk Management and Knowledge Management, ensuring compliance with ICH Q9, ICH Q10, ICH E6 and global regulatory standards. This role supports the organization’s shift toward a predictive, intelligence-driven model while overseeing the effective implementation of Quality Risk Management (ICH Q9) and the Pharmaceutical Quality System (ICH Q10) across GMP, GCP, GLP, GVP, and GDP-regulated activities. It encompasses all product modalities, including small molecules, biologics, cell and gene therapies, and medical devices.

This role partners closely with Program Quality, Quality Systems, Compliance, Data & Digital teams, and senior leadership to translate quality signals and insights into enterprise risk visibility and proactive mitigation strategies.

This role requires strong leadership and technical skills, the ability to operate in a matrix organization as well as the ability to be independent and autonomous.  This individual will demonstrate Vertex Core Values, as well as model leadership behaviors instilling a culture of quality, engagement, development, and transparency. 

KEY RESPONSIBILITIES:

Global GxP Governance / Quality Management Review Ownership

Serve as the Global Process Owner for Global Governance / Management Review process across all GxP domains.

Responsibilities include supporting the Global Governance Owner to:

• Design, implement, and maintain an integrated Global Quality Governance Model across GxP domains
• Define tiered governance structures aligned to risk criticality and decision authority
• Establish clear RACI and decision rights across Global Quality System Owners, Process Owners, quality operations, and business functions
• Ensure alignment of governance across QMS elements
• Partner with senior leadership to ensure governance forums drive action, not just reporting
• Enable end-to-end traceability from signal to risk to decision to action to effectiveness check

Global GxP Risk Management Ownership

Serve as the Global Process Owner for Quality Risk Management (QRM) across all GxP domains.

Responsibilities include supporting the QRM Quality System Owner by:

• Managing and maintaining the Global Quality Risk Management (QRM) framework in compliance with ICH Q9, ICH Q10, and global regulatory standards.
• Implementing standardized processes for risk identification, assessment, mitigation, and monitoring across the Quality Management System (QMS).
• Facilitating risk assessment sessions using appropriate tools and methodologies to ensure thorough evaluation and documentation of risks.
• Enabling the proactive identification and evaluation of systemic quality risks across programs, sites, and vendors.
• Collaborating with Program Quality teams and functional leaders to assess risks at both program and portfolio levels.
• Establishing clear mechanisms for escalating and reporting risks to Quality Leadership and governance bodies.
• Creating and maintaining risk dashboards and generating predictive insights using quality data and analytics.
• Leading risk reviews and supporting risk-based decision-making processes within governance forums.
• Designing and delivering targeted risk management training programs for the organization as needed.
• Ensuring seamless integration of risk management practices with key QMS components, including:
  • Deviations
  • Corrective and Preventive Actions (CAPA)
  • Change Control
  • Audit findings
  • Inspection observations

Global Quality Knowledge Management Ownership

Serve as the Global Process Owner for Quality Knowledge Management (KM) in alignment with alignment with ICH Q10, and global regulatory expectations

Responsibilities include supporting the QRM Quality System Owner by:

• Developing and maintaining a robust Global Quality Knowledge Management f