Digital Quality Systems Lead

Alnylam Pharmaceuticals, Inc.

United States

On-site

USD 164,500 - 222,500

Full time

14 days+

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Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Paid time off

Job summary

Alnylam Pharmaceuticals, Inc. is seeking an Associate Director, Digital Quality Compliance to own and advance Quality digital capabilities globally.

This virtual role partners with Quality, IT and business stakeholders to drive roadmap priorities, validation, data integrity and compliant operations across QA/QC systems such as Veeva, LIMS, SAP and DocuSign. You will translate complex Quality needs into clear requirements, enable cross-platform integrations, and ensure inspection readiness

Qualifications

Bachelor's degree in Life Sciences, Engineering, Computer Science, or related field.
8+ years of experience in Quality within biotechnology/pharmaceutical industries with GxP data domains.
5+ years of SAP experience in a Quality context (QM) with LIMS, MES, and QMS integrations.
7+ years of experience with Veeva Vault Quality or similar QMS technology.
Knowledge of ERP, LIMS, MES systems.
Experience with Quality Risk Management (ICH Q9).

Responsibilities

Lead the multi-year roadmap for Quality digital capabilities (SAP, Veeva, LIMS) and drive governance-driven improvements.
Translate complex Quality requirements into clear functional and system specifications.
Provide Quality ownership for QA/QC digital capabilities (Veeva, LIMS, SAP, Kneat, DocuSign).
Standardize Quality processes to reduce customization and enable global operations.
Evaluate IT features and drive adoption where value is demonstrated.
Support Quality data governance, reporting, and traceability for inspection readiness.
Oversee release planning and change control for QA/QC systems and validation artifacts.