Senior Director Quality Systems Jobs (NOW HIRING)

Overview
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 lifecyle 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.
Key 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

Required Qualifications

• 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

Preferred Qualifications

• 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

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U.S. Pay Range
$226,800.00 - $306,800.00
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.