Director, Clinical Quality Risk & Portfolio Oversight
Alnylam Pharmaceuticals
8 days ago
Remote
United States
Operations
Overview
The Director, Clinical Quality Risk & Portfolio Oversight leads enterprise-wide quality intelligence, portfolio risk surveillance, and centralized quality oversight across Clinical Development (remote).
Key Responsibilities
- Portfolio Quality Risk Surveillance: Lead enterprise-level quality surveillance; identify systemic quality risks and emerging operational vulnerabilities; analyze audits, inspections, CAPAs, deviations, monitoring, vendor oversight, and quality metrics to identify trends and risk patterns; establish proactive quality risk detection, escalation, and mitigation frameworks.
- Quality Analytics & Trend Management: Develop and maintain portfolio dashboards/analytics and governance reporting; perform cross-study/function/vendor/system trend analysis; translate complex quality data into actionable leadership insights; define and maintain risk indicators, thresholds, and escalation criteria.
- Vendor Quality Oversight Leadership: Provide scalable, risk-based vendor oversight (CROs, laboratories, technology providers, service partners), monitor third-party performance trends, and drive consistency across vendor governance.
- Clinical Systems Quality Oversight: Lead clinical systems quality governance; ensure quality/compliance requirements are built into technology platforms and lifecycle activities; partner with IT/Validation/Operations on system risks/controls; oversee computerized system risk evaluation and trend analysis; develop GLP and PV system governance oversight.
- Enterprise Risk Management & Governance: Maintain a centralized risk repository for threats to the clinical pipeline; partner with inspection readiness/QA leadership; create executive risk summaries; represent Clinical Quality on executive steering committees; collaborate across GLP and PV governance.
- Organizational Leadership: Manage Vendor Quality Oversight Lead and Clinical Systems Quality Lead; build scalable surveillance/analytics/governance capabilities; drive a proactive, data-driven quality culture.
Qualifications
- Bachelor’s degree in Life Sciences or related field (required); advanced degree preferred; training/certification in risk management, quality systems, or data analytics preferred.
- 10+ years in GCP Quality Assurance/Clinical Quality/Clinical Operations or related GCP roles (pharma/biotech/CRO).
- Proven experience leading enterprise quality oversight and portfolio risk surveillance with risk-based quality frameworks.
- Strong quality metrics, dashboards, and analytics proficiency; ability to interpret compliance signals.
- Strategic, analytical problem-solver; translates risk insights to actionable, executive reporting.
- Strong leadership and cross-functional influence (Clinical Ops, Regulatory, Data Mgmt, Digital/Systems, vendors).
- Deep knowledge of ICH GCP, FDA, EMA, and global clinical regulatory requirements.
The Director, Clinical Quality Risk & Portfolio Oversight leads enterprise-wide quality intelligence, portfolio risk surveillance, and centralized quality oversight across Clinical Development (remote).
Key Responsibilities
- Portfolio Quality Risk Surveillance: Lead enterprise-level quality surveillance; identify systemic quality risks and emerging operational vulnerabilities; analyze audits, inspections, CAPAs, deviations, monitoring, vendor oversight, and quality metrics to identify trends and risk patterns; establish proactive quality risk detection, escalation, and mitigation frameworks.
- Quality Analytics & Trend Management: Develop and maintain portfolio dashboards/analytics and governance reporting; perform cross-study/function/vendor/system trend analysis; translate complex quality data into actionable leadership insights; define and maintain risk indicators, thresholds, and escalation criteria.
- Vendor Quality Oversight Leadership: Provide scalable, risk-based vendor oversight (CROs, laboratories, technology providers, service partners), monitor third-party performance trends, and drive consistency across vendor governance.
- Clinical Systems Quality Oversight: Lead clinical systems quality governance; ensure quality/compliance requirements are built into technology platforms and lifecycle activities; partner with IT/Validation/Operations on system risks/controls; oversee computerized system risk evaluation and trend analysis; develop GLP and PV system governance oversight.
- Enterprise Risk Management & Governance: Maintain a centralized risk repository for threats to the clinical pipeline; partner with inspection readiness/QA leadership; create executive risk summaries; represent Clinical Quality on executive steering committees; collaborate across GLP and PV governance.
- Organizational Leadership: Manage Vendor Quality Oversight Lead and Clinical Systems Quality Lead; build scalable surveillance/analytics/governance capabilities; drive a proactive, data-driven quality culture.
Qualifications
- Bachelor’s degree in Life Sciences or related field (required); advanced degree preferred; training/certification in risk management, quality systems, or data analytics preferred.
- 10+ years in GCP Quality Assurance/Clinical Quality/Clinical Operations or related GCP roles (pharma/biotech/CRO).
- Proven experience leading enterprise quality oversight and portfolio risk surveillance with risk-based quality frameworks.
- Strong quality metrics, dashboards, and analytics proficiency; ability to interpret compliance signals.
- Strategic, analytical problem-solver; translates risk insights to actionable, executive reporting.
- Strong leadership and cross-functional influence (Clinical Ops, Regulatory, Data Mgmt, Digital/Systems, vendors).
- Deep knowledge of ICH GCP, FDA, EMA, and global clinical regulatory requirements.