Associate Director, Global GxP Governance, Risk & Intelligence

Vertex Inc. • Boston, MA

2d • Hybrid

About The Position

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.

Requirements

• 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.

Nice To Haves

• Professional association membership and participation preferred, not required (for example: RAPS; Lean Six Sigma training/certification; SQA (GCP/GLP); ASQ; DIA)

Responsibilities

• Global GxP Governance / Quality Management Review Ownership Serve as the Global Process Owner for Global Governance / Management Review process across all GxP domains.
• Global GxP Risk Management Ownership Serve as the Global Process Owner for Quality Risk Management (QRM) across all GxP domains.
• 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
• Quality Intelligence & Signal Detection Support the evolution toward a Quality Intelligence model by integrating data, risk signals, and knowledge insights.
• Governance & Leadership Engagement Lead or support GxP quality governance forums
• 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

Benefits

• This role is eligible for an annual bonus and annual equity awards.
• Some roles may also be eligible for overtime pay, in accordance with federal and state requirements.
• At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.
• From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 501-1,000 employees