Associate Director, Global GxP Governance, Risk & Intelligence
Vertex Pharmaceuticals
4 hours ago
Remote friendly (Boston, MA)
United States
Operations
GENERAL POSITION SUMMARY
- Lead Global GxP Governance, Risk Management, and Knowledge Management programs to strengthen proactive quality oversight.
- Integrate risk intelligence, data insights, and organizational knowledge to enable informed decision-making, regulatory compliance, and continuous improvement across the global Quality Management System (QMS).
- Serve as global process owner for GxP Governance, Risk Management, and Knowledge Management, ensuring compliance with ICH Q9, ICH Q10, ICH E6, and global regulatory standards.
KEY RESPONSIBILITIES
Global GxP Governance / Quality Management Review Ownership
- Serve as Global Process Owner for Global Governance / Management Review across all GxP domains.
- Support development of an integrated Global Quality Governance Model; define tiered governance aligned to risk criticality; establish RACI/decision rights; ensure QMS element alignment; ensure governance forums drive action (not just reporting); enable traceability from signal → risk → decision → action → effectiveness check.
Global GxP Risk Management Ownership
- Serve as Global Process Owner for Quality Risk Management (QRM) across all GxP domains.
- Maintain the Global QRM framework (ICH Q9/ICH Q10 and global standards); implement standardized risk processes (identify/assess/mitigate/monitor); facilitate risk assessment sessions; identify systemic quality risks across programs/sites/vendors; collaborate with Program Quality and functional leaders at program and portfolio levels; establish risk escalation/reporting mechanisms; create risk dashboards and predictive insights; lead risk reviews and risk-based decision-making.
- Integrate risk management with Deviation, CAPA, Change Control, audit findings, and inspection observations.
Global Quality Knowledge Management Ownership
- Serve as Global Process Owner for Quality Knowledge Management (aligned with ICH Q10 and global regulatory expectations).
- Build/maintain a Global Quality Knowledge Management framework; oversee capture/organization/accessibility of quality knowledge across the product lifecycle.
- Establish systems to collect/manage insights from deviations, inspections, audits, regulatory feedback, investigations, and lessons learned; enable cross-program/cross-site knowledge sharing; collaborate with Digital/IT on repositories and intelligence platforms; standardize knowledge capture, taxonomy, and lifecycle management; drive organizational learning and continuous improvement via knowledge transfer.
Quality Intelligence & Signal Detection
- Evolve toward a Quality Intelligence model by integrating data, risk signals, and knowledge insights.
- Analyze quality data trends for emerging risks/systemic issues; establish signal detection/early risk identification mechanisms; partner with Quality Data & Analytics to build GxP dashboards/insights; translate data into actionable risk intelligence; support development of predictive quality monitoring.
Governance & Leadership Engagement
- Lead/support GxP quality governance forums; provide risk intelligence to Quality Leadership.
- Support inspection readiness by ensuring risk visibility and documented mitigation strategies; present enterprise risk intelligence to Quality Councils and senior leadership.
Cross-Functional Collaboration
- Act as a change agent to embed an enterprise quality mindset across modalities (small molecule, cell/gene, device, biologics), GxP areas, and geographies.
- Model leadership behaviors (transparency, openness, respect, partnership); partner to embed risk-based quality oversight.
QUALIFICATIONS / SKILLS / COMPETENCIES
Quality Risk Management Expertise
- Extensive hands-on QRM experience aligned to ICH Q9 and applied within ICH Q10.
- Experience designing/implementing/governing risk management frameworks across diverse GxP domains (GMP, GCP, GLP, GVP, GDP), modalities, and global geographies.
- Experience managing enterprise risk registers, creating risk escalation frameworks, and governance models for risk-based decision-making.
- Ability to proactively identify, assess, and address systemic and emerging risks across programs, vendors, sites, and quality systems.
Quality Intelligence & Data-Driven Oversight
- Ability to translate complex quality data into actionable risk intelligence and strategic insights.
- Experience using quality metrics, advanced analytics, and digital dashboards to detect signals and enable proactive mitigation.
- Capability to support predictive quality monitoring and signal detection models.
- Strong analytical skills synthesizing deviations, CAPAs, audits, inspections, complaints, and operational metrics.
Global Process Ownership
- Experience as Global Process Owner or enterprise lead for critical quality systems.
- Deep knowledge of Pharmaceutical Quality Management Systems and integration of risk management across deviations, CAPA, change control, audit/inspection management, and supplier quality.
Quality Knowledge Management
- Strong understanding of Quality Knowledge Management principles under ICH Q10.
- Experience designing knowledge capture, taxonomy, and lifecycle frameworks.
- Ability to establish repositories and mechanisms to capture insights from inspections, investigations, audits, and lessons learned; enable cross-site/program knowledge sharing.
Governance, Inspection Readiness & Regulatory Engagement
- Deep understanding of global regulatory expectations (FDA, EMA, MHRA, and others).
- Experience supporting regulatory inspections, inspection readiness, and responses to regulatory observations.
- Ability to present risk intelligence/quality insights to senior leadership and governance forums.
Enterprise Leadership & Cross-Functional Influence
- Ability to operate in complex global matrix organizations and influence across functions, programs, and geographies.
- Leadership facilitating risk governance forums and enterprise quality councils.
- Ability to build partnerships across Program Quality, Quality Systems, Compliance, Regulatory, Manufacturing, Clinical, and Digital teams.
- Ability to serve as a change agent driving proactive, risk-based quality culture.
Operational Excellence & Continuous Improvement
- Experience leading process improvement using root cause analysis, Lean, DMAIC, and Six Sigma.
- Ability to design and implement KPIs and health indicators for Quality Systems performance.
Leadership & Organizational Capability Building
- Ability to develop individuals and build high-performing teams in a multi-level matrix organization.
- Strong communication/influencing skills; promote quality, transparency, and continuous improvement.
- Creative, innovative leadership with change management and organizational transformation experience.
PREFERRED EDUCATION AND EXPERIENCE
- M.S. (or equivalent) with 8+ years relevant experience, or B.S. in a scientific/allied health field (or equivalent) with 10+ years relevant experience, or comparable background.
- Professional association membership/participation preferred (e.g., RAPS; Lean Six Sigma training/certification; SQA (GCP/GLP); ASQ; DIA).
PAY / BENEFITS (as stated)
- Pay range: $148,000 - $222,000.
- Eligible for annual bonus and annual equity awards; some roles may be eligible for overtime pay.
- Total Rewards include medical/dental/vision, paid time off, educational assistance/student loan repayment, commuting subsidy, matching charitable donations, 401(k), and more.
FLEX DESIGNATION (as stated)
- Hybrid-Eligible: Hybrid (remote up to two days/week) or On-Site (five days/week on-site with ad hoc flexibility).
APPLICATION INSTRUCTIONS (as stated)
- For accommodation requests: ApplicationAssistance@vrtx.com
- Lead Global GxP Governance, Risk Management, and Knowledge Management programs to strengthen proactive quality oversight.
- Integrate risk intelligence, data insights, and organizational knowledge to enable informed decision-making, regulatory compliance, and continuous improvement across the global Quality Management System (QMS).
- Serve as global process owner for GxP Governance, Risk Management, and Knowledge Management, ensuring compliance with ICH Q9, ICH Q10, ICH E6, and global regulatory standards.
KEY RESPONSIBILITIES
Global GxP Governance / Quality Management Review Ownership
- Serve as Global Process Owner for Global Governance / Management Review across all GxP domains.
- Support development of an integrated Global Quality Governance Model; define tiered governance aligned to risk criticality; establish RACI/decision rights; ensure QMS element alignment; ensure governance forums drive action (not just reporting); enable traceability from signal → risk → decision → action → effectiveness check.
Global GxP Risk Management Ownership
- Serve as Global Process Owner for Quality Risk Management (QRM) across all GxP domains.
- Maintain the Global QRM framework (ICH Q9/ICH Q10 and global standards); implement standardized risk processes (identify/assess/mitigate/monitor); facilitate risk assessment sessions; identify systemic quality risks across programs/sites/vendors; collaborate with Program Quality and functional leaders at program and portfolio levels; establish risk escalation/reporting mechanisms; create risk dashboards and predictive insights; lead risk reviews and risk-based decision-making.
- Integrate risk management with Deviation, CAPA, Change Control, audit findings, and inspection observations.
Global Quality Knowledge Management Ownership
- Serve as Global Process Owner for Quality Knowledge Management (aligned with ICH Q10 and global regulatory expectations).
- Build/maintain a Global Quality Knowledge Management framework; oversee capture/organization/accessibility of quality knowledge across the product lifecycle.
- Establish systems to collect/manage insights from deviations, inspections, audits, regulatory feedback, investigations, and lessons learned; enable cross-program/cross-site knowledge sharing; collaborate with Digital/IT on repositories and intelligence platforms; standardize knowledge capture, taxonomy, and lifecycle management; drive organizational learning and continuous improvement via knowledge transfer.
Quality Intelligence & Signal Detection
- Evolve toward a Quality Intelligence model by integrating data, risk signals, and knowledge insights.
- Analyze quality data trends for emerging risks/systemic issues; establish signal detection/early risk identification mechanisms; partner with Quality Data & Analytics to build GxP dashboards/insights; translate data into actionable risk intelligence; support development of predictive quality monitoring.
Governance & Leadership Engagement
- Lead/support GxP quality governance forums; provide risk intelligence to Quality Leadership.
- Support inspection readiness by ensuring risk visibility and documented mitigation strategies; present enterprise risk intelligence to Quality Councils and senior leadership.
Cross-Functional Collaboration
- Act as a change agent to embed an enterprise quality mindset across modalities (small molecule, cell/gene, device, biologics), GxP areas, and geographies.
- Model leadership behaviors (transparency, openness, respect, partnership); partner to embed risk-based quality oversight.
QUALIFICATIONS / SKILLS / COMPETENCIES
Quality Risk Management Expertise
- Extensive hands-on QRM experience aligned to ICH Q9 and applied within ICH Q10.
- Experience designing/implementing/governing risk management frameworks across diverse GxP domains (GMP, GCP, GLP, GVP, GDP), modalities, and global geographies.
- Experience managing enterprise risk registers, creating risk escalation frameworks, and governance models for risk-based decision-making.
- Ability to proactively identify, assess, and address systemic and emerging risks across programs, vendors, sites, and quality systems.
Quality Intelligence & Data-Driven Oversight
- Ability to translate complex quality data into actionable risk intelligence and strategic insights.
- Experience using quality metrics, advanced analytics, and digital dashboards to detect signals and enable proactive mitigation.
- Capability to support predictive quality monitoring and signal detection models.
- Strong analytical skills synthesizing deviations, CAPAs, audits, inspections, complaints, and operational metrics.
Global Process Ownership
- Experience as Global Process Owner or enterprise lead for critical quality systems.
- Deep knowledge of Pharmaceutical Quality Management Systems and integration of risk management across deviations, CAPA, change control, audit/inspection management, and supplier quality.
Quality Knowledge Management
- Strong understanding of Quality Knowledge Management principles under ICH Q10.
- Experience designing knowledge capture, taxonomy, and lifecycle frameworks.
- Ability to establish repositories and mechanisms to capture insights from inspections, investigations, audits, and lessons learned; enable cross-site/program knowledge sharing.
Governance, Inspection Readiness & Regulatory Engagement
- Deep understanding of global regulatory expectations (FDA, EMA, MHRA, and others).
- Experience supporting regulatory inspections, inspection readiness, and responses to regulatory observations.
- Ability to present risk intelligence/quality insights to senior leadership and governance forums.
Enterprise Leadership & Cross-Functional Influence
- Ability to operate in complex global matrix organizations and influence across functions, programs, and geographies.
- Leadership facilitating risk governance forums and enterprise quality councils.
- Ability to build partnerships across Program Quality, Quality Systems, Compliance, Regulatory, Manufacturing, Clinical, and Digital teams.
- Ability to serve as a change agent driving proactive, risk-based quality culture.
Operational Excellence & Continuous Improvement
- Experience leading process improvement using root cause analysis, Lean, DMAIC, and Six Sigma.
- Ability to design and implement KPIs and health indicators for Quality Systems performance.
Leadership & Organizational Capability Building
- Ability to develop individuals and build high-performing teams in a multi-level matrix organization.
- Strong communication/influencing skills; promote quality, transparency, and continuous improvement.
- Creative, innovative leadership with change management and organizational transformation experience.
PREFERRED EDUCATION AND EXPERIENCE
- M.S. (or equivalent) with 8+ years relevant experience, or B.S. in a scientific/allied health field (or equivalent) with 10+ years relevant experience, or comparable background.
- Professional association membership/participation preferred (e.g., RAPS; Lean Six Sigma training/certification; SQA (GCP/GLP); ASQ; DIA).
PAY / BENEFITS (as stated)
- Pay range: $148,000 - $222,000.
- Eligible for annual bonus and annual equity awards; some roles may be eligible for overtime pay.
- Total Rewards include medical/dental/vision, paid time off, educational assistance/student loan repayment, commuting subsidy, matching charitable donations, 401(k), and more.
FLEX DESIGNATION (as stated)
- Hybrid-Eligible: Hybrid (remote up to two days/week) or On-Site (five days/week on-site with ad hoc flexibility).
APPLICATION INSTRUCTIONS (as stated)
- For accommodation requests: ApplicationAssistance@vrtx.com