Sr. Manager, Quality Technology and Analytics

Alnylam Pharmaceuticals • Cambridge, MA

1d • Remote

About The Position

The Sr. Manager, Quality Technology and Analytics will serve as a strategic business and systems analyst within the Quality Technology and Analytics (QTA) organization, supporting the Quality and GXP enterprise functions globally. This role is responsible for driving data quality and data hygiene programs, delivering actionable analytics and operational insights, and supporting efforts to optimize oversight and compliance of GxP computerized systems.
The Sr. Manager will partner closely with Quality, Manufacturing, Regulatory, Pharmacovigilance, R&D and IT stakeholders to strengthen data integrity, improve system usability and adoption, and enable scalable, inspection-ready digital processes. The role will play a critical part in establishing standardized data practices, supporting continuous improvement initiatives, and enabling future digital and analytics capabilities across the Quality Management System landscape.
This position resides within the Quality Technology and Analytics Department and reports to the Associate Director, Quality Systems
This role is considered Virtual.

Requirements

• Bachelor’s degree in Information Systems, Computer Science, Engineering, Life Sciences, or a related discipline required; advanced degree preferred.
• 10+ years of experience supporting GxP computerized systems within a regulated biopharmaceutical or life sciences environment.
• Demonstrated experience serving as a senior business and systems analyst for Quality and regulated business functions, including Manufacturing, Quality, Regulatory and/or R&D.
• Demonstrated experience administering and supporting Veeva Quality Vault, including configuration governance, user and role management, metadata and object configuration, reporting, and release impact assessment.
• Demonstrated experience in data analysis, analytics, and visualization, including the design, development, and ongoing maintenance of reporting and insight solutions using platforms such as Veeva Vault reporting, Smartsheet, Power BI, and Tableau, to support operational decision-making and Quality performance monitoring and executive-level data presentation.
• Experience working with enterprise data lake and cloud analytics platforms, including hands-on experience with Snowflake, to support ingestion, transformation, and consumption of Quality and GxP system data, and to enable scalable analytics, reporting, and data-driven insights across the Quality technology landscape.
• Strong working knowledge of CSV / CSA / validation lifecycle activities.
• Proven experience leading and governing GxP system change management, including change impact assessments and validation alignment.
• Proven experience leading data quality and data hygiene initiatives in regulated systems, including establishing data standards, remediation of data issues and establishment of sustainable data quality controls.
• Demonstrated experience contributing to and owning Quality compliance activities related to computerized systems, including deviations, CAPAs, periodic system reviews, and audit/inspection support.
• Solid understanding of global regulatory expectations related to computerized systems and data integrity, including 21 CFR Part 11, Annex 11, and data integrity principles.

Nice To Haves

• Master's degree in related field
• Experience with system integration and data migration projects
• Experience with Agile methodologies and software development lifecycle processes
• Experience supporting or integrating additional Quality platforms (e.g., LIMS, MES, CMMS, LMS)

Responsibilities

• Serve as a strategic business analyst within the Quality Technology & Analytics (QTA) organization, supporting global Quality and GxP functions across Manufacturing, Regulatory, R&D and IT.
• In collaboration with IT, support efforts to ensure system administration, configuration oversight and operational support for GxP computerized systems, with primary accountability for Veeva Quality Vault platform.
• Support validation activities for QA owned systems, including requirements gathering, design review, user acceptance testing, test script review and execution, discrepancy management, and validation summary report authoring.
• Own and manage implementation and execution of system enhancements (IT Change Orders) across Veeva Quality Vault applications, ensuring appropriate impact assessment, validation alignment and stakeholder coordination.
• Lead intake, triage and resolution of end user requests, including review of ServiceNow tickets to ensure management, d troubleshooting, escalation and root cause analysis.
• Deliver operational reporting, dashboards and analytics to support Quality performance, inspection readiness and leadership decision-making, including development, maintenance and enhancements of Veeva reports and dashboards.
• Drive data quality and data hygiene initiatives across Veeva Quality Vault and other Quality owned systems ensuring standardized data practices, reporting and inspection readiness.
• Contributes to Quality compliance activities, including CAPA and deviation ownership related to QA owned systems data issues and compliance. Lead or supports periodic system reviews.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level