Associate Director, Quality Technology Delivery

Overview

Alnylam is seeking a results-oriented and execution-focused leader to serve as Associate Director, Quality Technology Delivery, responsible for delivering and supporting IT systems that enable Quality Management System (QMS) processes across Research & Development (R&D) and Technical Operations & Quality (TOQ).

This role will focus on the implementation, integration, and continuous improvement of technology solutions that support the QMS and enable quality management, compliance, and operational excellence across GxP (Good Practice) environments. The Associate Director will work closely with Quality stakeholders, IT partners, and vendors to ensure solutions are delivered effectively, meet business needs, and operate reliably at scale.

Reporting to the Senior Director, Quality Technology, this role will play a key part in translating strategy into execution, ensuring that Quality technology initiatives are delivered on time, within scope, and aligned with business priorities.

This role operates within a model where Quality owns QMS processes and governance, and IT delivers and supports the enabling technology platforms.

Key Responsibilities

Lead Delivery of Technology Systems Supporting QMS Processes

• Manage implementation, enhancement, and integration of technology platforms that support QMS processes, including:
  • Veeva Quality Suite (QMS, Docs, Training, etc.)
  • LabWare Laboratory Information Management System (LIMS) for Quality and Quality Control (QC) lab environments
• SAP S/4 Quality Management (QM) and related Quality modules
• Ensure solutions are delivered on time, within scope, and aligned with business requirements
• Drive issue resolution, risk management, and escalation as needed

Manage Technology Vendor Delivery and System Operations

• Oversee day-to-day execution of vendor-delivered work across Quality systems
• Ensure vendors meet agreed timelines, IT standards, and service levels
• Coordinate across multiple vendors and internal teams to deliver integrated solutions
• Support ongoing system operations, including incident management, enhancements, and upgrades

Partner with Quality to Enable Effective Solutions

• Work closely with Quality stakeholders to understand business needs and translate them into IT system requirements
• Ensure solutions align with Quality-owned business processes and workflows, and enable standardized, scalable ways of working
• Support user readiness and enablement, with adoption led by Quality and other business stakeholders
• Act as a trusted partner to Quality teams for system-related needs and improvements

Support Data Integration and Reporting (in partnership with IT Data & Artificial Intelligence (AI)

• Support integration of Quality IT systems with upstream and downstream systems
• Collaborate with IT Data & AI to ensure Quality data is captured, structured, and accessible for reporting and analytics
• Enable consistent data flows across lab, manufacturing, and Quality domains
• Help ensure data quality, consistency, and traceability across systems

Ensure Compliance, Validation, and Data Integrity

•  Ensure all delivered solutions meet GxP, validation, and regulatory requirements
• Partner with Quality and IT Validation teams to support:
  • Computer System Validation (CSV) and Computer Software Assurance (CSA), and Quality assurance efforts
  • Audit and inspection readiness
• Ensure appropriate controls, documentation, and system lifecycle processes are followed
• Support data integrity practices across Quality systems

Drive Continuous Improvement

• Identify opportunities to improve system performance, usability, and efficiency
• Drive standardization and simplification of system-related processes
• Support ongoing roadmap execution defined by the Senior Director
• Contribute to improving delivery processes, tools, and governance

Required Qualifications

• B.S., M.S., or Ph.D. in a science or engineering discipline
• 10+ years of experience supporting Quality IT systems in life sciences
• Strong understanding of GxP, Quality processes, and regulatory requirements
• Proven experience delivering enterprise systems (e.g., Veeva)
• Experience managing system implementations and working with external vendors
• Strong program and project management skills
• Ability to work effectively with business stakeholders and cross-functional teams
• Experience operating in regulated environments with audit/inspection exposure

Preferred Qualifications