Senior Director, Quality Technology

Alnylam Pharmaceuticals•Cambridge, MA

1d•$226,800 - $306,800•Hybrid

About The Position

Alnylam is seeking a strategic and technology-savvy leader to serve as Senior Director, Quality Technology, responsible for advancing digital capabilities across Quality functions spanning Research & Development (R&D) and Technical Operations & Quality (TOQ). This role will partner with the Quality organization to define, refine, and execute the Quality technology strategy and digital roadmap, including IT systems, data, and AI-enabled capabilities that support Quality Management System (QMS) processes, compliance, and operational excellence across GxP environments. The Senior Director will partner closely with Quality leaders and key stakeholders to transform Quality digital platforms and enable data-driven QMS execution. This is a strategic leadership role with a strong focus on business partnership, technology system lifecycle management, and execution. The role requires a solid understanding of Quality systems, data, architecture, and integration, along with the ability to work closely with IT Data/AI, Infrastructure, and Cybersecurity & Digital Risk teams to deliver scalable and compliant solutions. The role will be responsible for the lifecycle management of the Quality-related applications, including platforms such as Veeva (Quality Modules), LabWare LIMS, SAP S/4 QM, and related systems, ensuring they are effectively implemented, integrated, and continuously improved and supported. The Senior Director will serve as the primary IT partner to Quality leadership, contributing to digital strategy, governance, and cross-functional digital initiatives across R&D and TOQ. This role operates within a model where Quality owns QMS processes and governance, and IT leads the strategy, delivery, and lifecycle management of the technology platforms that enable the QMS.

Requirements

B.S., M.S., or Ph.D. in a science or engineering discipline
15+ years of experience in IT supporting Quality in life sciences
Strong understanding of GxP, Quality processes, and regulatory requirements
Proven experience leading enterprise system implementations (e.g., Veeva, Labware, SAP)
Solid understanding of enterprise systems, data, and integration concepts
Demonstrated ability to partner effectively with senior business and Quality and IT leaders
Experience operating in regulated environments with audit/inspection exposure

Nice To Haves

Familiarity with enterprise data platforms (e.g., Snowflake) and data integration patterns
Experience working with Enterprise Data/AI teams on data modeling and analytics
Exposure to analytics, reporting, or AI use cases in Quality
Experience contributing to system architecture, integration design, or technology strategy
Strong understanding of data governance and data integrity frameworks
Experience supporting end-to-end product lifecycle

Responsibilities

Own the Quality Technology Strategy & Application Portfolio in partnership with Quality
Define and execute the end-to-end Quality technology strategy across R&D and TOQ in partnership with Quality, ensuring alignment to QMS processes, lifecycle requirements, and governance frameworks
Own the lifecycle (selection, implementation, integration, enhancement, and retirement) of technology platforms supporting the QMS, including: Veeva Quality Suite (QMS, Docs, Training, etc.), LabWare LIMS (Quality and QC lab environments), SAP S/4 QM and related Quality modules, Other Quality and compliance-related applications
Ensure IT systems are reliable, scalable, and aligned with evolving business needs and QMS standardization and continuous improvement objectives
Partner with enterprise architecture, platform, infrastructure, cybersecurity & digital risk teams to align with broader IT standards
Lead Delivery with Vendor Oversight and Accountability
Oversee delivery and ongoing support of IT systems enabling QMS processes
Retain ownership and provide end-to-end oversight across all technology vendor-delivered work
Ensure technology vendor activities align with business priorities, timelines, IT standards, and compliance requirements
Establish clear governance, performance management, and accountability for vendor partners
Enable Quality Data Strategy & Integration (in partnership with Quality and IT Data & AI)
Partner with Quality and IT Data & AI teams to define Quality data models, standards, and integration patterns aligned with QMS data and process requirements
Enable seamless Quality data flow across systems supporting the QMS lifecycle
Ensure Quality data is effectively integrated into the enterprise data platform
Enable strong data governance, lineage, and quality for GxP data
Enable Analytics and AI-Driven Quality Insights (in partnership with Quality, IT Data & AI, and Cybersecurity & Digital Risk)
Enable high-value analytics and AI use cases in Quality, including: Quality Management System (QMS) performance monitoring and service optimization, Risk identification and predictive quality insights, Predictive analytics for system health, capacity and operational risk
Partner with Quality, IT Data/AI, and Cybersecurity & Digital Risk to operationalize these capabilities at scale
Ensure IT System Compliance, Validation, and Data Integrity (in partnership with Cyber Security & Digital Risk, and Quality)
Ensure all IT systems supporting the QMS meet GxP, validation, and regulatory requirements
Partner with Quality and IT Validation teams to support: Computer system validation (CSV) and system assurance efforts, Audit and inspection readiness
Enable data integrity standards across systems supporting QMS processes and controls
Establish scalable processes for system lifecycle management (implementation, validation, upgrades, retirement)
Business & Technology Partnership
Serve as the primary IT partner to Quality leadership
Translate business priorities into technology roadmaps and solutions in partnership with Quality stakeholders, ensure alignment with QMS process design and governance
Support process standardization, simplification, and scalability across QMS-enabled operations
Enable cross-functional alignment
Oversee Delivery and Enable Adoption
Oversee successful implementation of technology platforms supporting QMS processes and digital capabilities
Partner with Quality stakeholders and other business stakeholders to enable adoption and ensure solutions meet business needs
Support change management efforts, with adoption led by Quality and other business stakeholders
Collaborate with stakeholders to balance standardization and flexibility
Build and develop a high-performing Quality Technology team