Director, Quality Assurance

Director, Clinical Quality Risk & Portfolio Oversight Overview The Director, Clinical Quality Risk & Portfolio Oversight leads enterprise-wide quality intelligence, portfolio risk surveillance, and centralized quality oversight activities across Clinical Development. This role is responsible for identifying emerging quality signals, systemic compliance risks, and operational trends across studies, vendors, computerized systems, audits, inspections, deviations, CAPAs, and quality metrics. Through data-driven analytics and risk-based oversight, the position enables a shift from study-level quality management to proactive, enterprise-wide quality risk management. This position serves as a strategic quality governance and quality analytics leader, partnering closely with other QA functions (including GLP and PV), functional Expertise Areas, Digital/Systems teams, and Functional Leadership. The role leads a team responsible for vendor quality oversight and clinical systems quality governance to drive standardized, risk-based oversight frameworks that enhance vendor performance management, system compliance, and overall quality across R&D. The role plays a critical part in strengthening a proactive, portfolio-wide quality model by leveraging trend analysis, risk insights, and centralized oversight to enhance compliance, inspection readiness, and operational effectiveness. This position is open to remote working. Key Responsibilities 1. Portfolio Quality Risk Surveillance * Lead enterprise-level quality surveillance activities across the clinical development portfolio. * Identify systemic quality risks, recurring compliance signals, and emerging operational vulnerabilities that may not be visible at the individual study level. * Analyze data from audits, inspections, CAPAs, deviations, site and central monitoring activities, vendor oversight, and quality metrics to identify trends and risk patterns. * Establish and maintain proactive quality risk detection, escalation, and mitigation frameworks. 2. Quality Analytics & Trend Management * Develop and maintain portfolio-level dashboards, analytics, and governance reporting to support quality oversight and leadership visibility. * Use data analytics to drive trend analysis across studies, functions, vendors, and systems to identify systemic/enterprise compliance concerns, opportunities for improvement, and emerging risks. * Translate complex quality data into actionable insights and recommendations for leadership. * Define and maintain meaningful risk indicators, thresholds, and escalation criteria. 3. Vendor Quality Oversight Leadership * Leads strategic oversight of clinical vendor quality management and establishes scalable oversight frameworks to enable broader application across Research and Development, including pre-clinical (GLP) and post-market (PV) domains. * Monitor CRO and third-party performance trends to identify systemic or recurring quality and compliance concerns. * Ensure risk-based oversight frameworks are implemented for CROs, laboratories, technology providers, and key service partners. * Drive consistency in vendor quality governance and risk management approaches. 4. Clinical Systems Quality Oversight * Provide leadership and oversight for clinical systems quality governance. * Ensure quality and compliance requirements are incorporated into clinical technology platforms and system lifecycle activities. * Partner with IT, Validation, and Operational stakeholders to assess and manage system-related quality risks and controls. * Oversee risk evaluation and trend analysis associated with computerized systems supporting GCP study related activities. * Develops quality oversight framework that will ensure GLP and PV system governance. 5. Enterprise Risk Management & Governance * Maintain and evolve a centralized risk repository that tracks high-level threats to the global clinical pipeline. * Partner with inspection readiness and QA leadership teams to identify enterprise risk areas requiring proactive mitigation. * Convert complex data into executive-level risk summaries and recommendations to support strategic decision-making. * Represent Clinical Quality in executive steering committees to ensure quality trends are factored into high-level business decisions. * Collaborates with risk management and governance bodies across GLP and PV R&D activities. 6. Organizational Leadership * Directly manage and develop: * Vendor Quality Oversight Lead * Clinical Systems Quality Lead * Build scalable quality surveillance, analytics, and governance capabilities across the organization. * Drive a culture of proactive risk identification and data-driven quality management. * Provide strategic leadership within the Clinical Quality organization. Qualifications Education * Bachelor’s degree in Life Sciences or related field required * Advanced degree preferred * Professional training or certification in risk management, quality systems, or data analytics preferred Experience * Minimum of 10 years of experience in GCP Quality Assurance, Clinical Quality, Clinical Operations, or related GCP-focused roles within the pharmaceutical, biotechnology, or CRO industry * Demonstrated experience leading enterprise-level quality oversight and portfolio risk surveillance, including the design and implementation of risk-based quality management frameworks and governance models * Strong proficiency in quality metrics, dashboards, and analytics, with the ability to interpret complex data and compliance signals to identify systemic risks, emerging trends, and opportunities for proactive action * Strategic thinker with strong analytical and problem-solving skills, capable of translating risk insights into actionable recommendations and executive-level reporting * Strong leadership, communication, and stakeholder management skills, with the ability to influence across all organizational levels and partner effectively with cross-functional teams, including Clinical Operations, Regulatory Affairs, Data Management, Digital/Systems, and external vendors * Deep knowledge of ICH GCP, FDA, EMA, and global clinical regulatory requirements * #LI-Virtual * #LI-AB1 U.S. Pay Range $192,600.00 - $260,600.00 The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity). Alnylam’s robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together. Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers About Alnylam We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another. At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.