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 framework to ensure alignment with organizational goals and regulatory requirements.
• Overseeing the systematic capture, organization, and accessibility of critical quality knowledge throughout the product lifecycle.
• Establishing and implementing efficient systems and processes to collect and manage insights from key sources, including:
  • Deviations
  • Inspections
  • Audits
  • Regulatory feedback
  • Investigations
  • Lessons learned
• Promoting cross-program and cross-site knowledge sharing to proactively prevent the recurrence of quality issues and foster best practices.
• Collaborating with Digital and IT teams to design and deploy knowledge repositories and advanced intelligence platforms for effective knowledge management.
• Defining and standardizing processes for knowledge capture, taxonomy, and lifecycle management to ensure consistency and usability.
• Driving organizational learning and fostering a culture of continuous improvement through structured knowledge transfer initiatives and best practice sharing.

Quality Intelligence & Signal Detection

Support the evolution toward a Quality Intelligence model by integrating data, risk signals, and knowledge insights.

Responsibilities include:

• Analyze quality data trends to identify emerging risks and systemic issues
• Establish mechanisms for quality signal detection and early risk identification
• Partner with Quality Data & Analytics teams to develop GxP quality dashboards and insights
• Translate quality data into actionable risk intelligence for leadership decision making
• Support development of predictive quality monitoring capabilities

Governance & Leadership Engagement

• Lead or support GxP quality governance forums
• Provide risk insights and intelligence to Quality Leadership
• Support inspection readiness by ensuring risk visibility and mitigation strategies are documented
• Present enterprise risk intelligence to Quality Councils and senior leadership teams

Cross-Functional Collaboration

• Serves as a change agent fostering an enterprise mindset and culture of quality across the organization while integrating and balancing needs across modalities (e.g., small molecule, cell, gene, device, biologics), GxP areas, and geographies
• Models' leadership, transparency, openness, respect, and partnership across interactions with staff, peers, customers, and stakeholder groups
• Partner across the organization to embed risk-based quality oversight.

Key Technical Knowledge, Skills and Competencies:

Quality Risk Management Expertise

• Extensive knowledge and hands-on experience with Quality Risk Management (QRM) principles in alignment with ICH Q9 and their practical application within the Pharmaceutical Quality System (ICH Q10).
• Demonstrated expertise in designing, implementing, and governing comprehensive risk management frameworks across diverse GxP domains (GMP, GCP, GLP, GVP, GDP), various product modalities, and global geographies.
• Proven experience in managing enterprise risk registers, developing risk escalation frameworks, and establishing governance models to support senior leadership in oversight and risk-based decision-making processes.
• Strong ability to proactively identify, assess, and address systemic and emerging risks across programs, vendors, sites, and quality systems, ensuring alignment with organizational and regulatory expectations.
• Proven ability to identify systemic and emerging risks across programs, vendors, sites, and quality systems.

Quality Intelligence & Data-Driven Oversight

• Strong ability to translate complex quality data into actionable risk intelligence and strategic insights.
• Experience leveraging quality metrics, advanced analytics, and digital dashboards to detect signals, identify trends, and enable proactive risk mitigation.
• Demonstrated capability to support development of predictive quality monitoring and signal detection models.
• Strong analytical skills with ability to synthesize data from deviations, CAPAs, audits, inspections, complaints, and operational metrics to identify systemic issues.

Global Process Ownership

• Demonstrated experience serving as Global Process Owner or enterprise lead for critical quality systems.
• Deep knowledge of Pharmaceutical Quality Management Systems and the integration of risk management across key QMS elements including:
  • Deviations
  • CAPA
  • Change Control
  • Audit & Inspection Management
  • Supplier Quality
• Proven ability to design, implement, and continuously improve global quality processes, governance structures, and enabling technologies.

Quality Knowledge Management

• Strong understanding of Quality Knowledge Management principles under ICH Q10 and their role in enabling organizational learning and lifecycle knowledge retention.
• Experience designing knowledge capture, taxonomy, and knowledge lifecycle frameworks across complex organizations.
• Ability to establish knowledge repositories and structured mechanisms for capturing insights from inspections, investigations, audits, and lessons learned.
• Experience enabling cross-site and cross-program knowledge sharing to prevent recurrence of quality issues.

Governance, Inspection Readiness & Regulatory Engagement

• Deep understanding of global regulatory expectations across FDA, EMA, MHRA, and other international agencies.
• Experience supporting regulatory inspections, inspection readiness programs, and responses to regulatory observations.
• Proven ability to present risk intelligence and quality insights to senior leadership and governance forums.

Enterprise Leadership & Cross-Functional Influence

• Proven ability to operate effectively within complex global matrix organizations, influencing across functions, programs, and geographies.
• Demonstrated leadership facilitating risk governance forums and enterprise quality councils.
• Strong ability to build partnerships across Program Quality, Quality Systems, Compliance, Regulatory, Manufacturing, Clinical, and Digital teams.
• Ability to serve as a change agent driving a proactive, risk-based culture of quality.

Operational Excellence & Continuous Improvement

• Demonstrated experience leading process improvement initiatives using structured problem-solving methodologies such as:
  • Root Cause Analysis
  • Lean
  • DMAIC
  • Six Sigma
• Proven ability to design and implement fit-for-purpose KPIs and health indicators for Quality Systems performance.

Leadership & Organizational Capability Building

• Demonstrated ability to develop individuals and build high-performing teams within a multi-level matrix organization.
• Strong communication and influencing skills with a proven ability to promote a culture of quality, transparency, and continuous improvement.
• Creative, innovative leadership complemented by strong change management and organizational transformation experience.

PREFERRED EDUCATION AND EXPERIENCE:

• M.S. (or equivalent degree) and 8+ years of relevant work experience, or B.S. in a scientific or allied health field (or equivalent degree) and 10+ years of relevant work experience, or relevant comparable background
• Professional association membership and participation preferred, not required (for example: RAPS; Lean Six Sigma training/certification; SQA (GCP/GLP); ASQ; DIA)

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Hybrid

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com