Associate Director, Digital Quality Compliance
Alnylam Pharmaceuticals
August 14, 2026
Remote
United States
Operations
Key Responsibilities:
- Lead the multi-year roadmap for Quality digital capabilities (emphasis on SAP, Veeva, and LIMS).
- Drive prioritization and delivery of Quality capability improvements through governance forums; align scope, risk, and adoption to strengthen GxP compliance, inspection readiness, and end-to-end process effectiveness with IT.
- Own QA/QC digital capabilities (e.g., Veeva, LIMS, SAP, Kneat, DocuSign, Ready Room) to ensure validated, compliant operation and value-driven enhancements with process owners, users, IT, and vendors.
- Translate Quality needs into clear, structured functional and system requirements; bridge Quality and IT (SAP & Veeva Center of Excellence).
- Drive standardization and simplification of Quality processes enabled through SAP/Veeva/LIMS; reduce customization for sustainable global operations.
- Evaluate IT feature/module impacts, determine Quality applicability, and lead adoption where value is demonstrated.
- Support Quality data governance (definitions, standards, traceability, lineage) for audit-ready reporting and reliable trending.
- Support release planning/change control for QA/QC systems; assess impacts to procedures, validation, training, and Quality records.
- Ensure inspection-ready documentation for Quality-owned capabilities aligned with the QMS.
- Guide Quality users/super-users on compliant system/data use; triage and escalate issues.
- Lead periodic reviews of system performance/compliance posture (access/roles, audit trails, data integrity controls, procedural adherence).
- Contribute to validation strategy using Quality Risk Management (risk-based validation).
- Maintain strong knowledge of Veeva Vault Quality, LIMS, and SAP best practices; coordinate end-to-end consistency across Vaults/GxP systems.
- Facilitate governance forums for Quality and TOQ capability requests.
Qualifications:
- Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related.
- 8+ years in Quality (biotech/pharma) with strong GxP Quality data domain knowledge (e.g., Deviations, CAPA, Change Control, Complaints, Materials Quality, Batch Disposition/Market Allocation; metrics).
- 5+ years working with SAP in a Quality context (SAP QM or equivalent) with integrations (LIMS, MES, QMS).
- 7+ years with Veeva Vault Quality (or similar QMS).
- Knowledge of complementary systems (ERP, LIMS, MES).
- Experience with Quality Risk Management (ICH Q9).
- Ability to translate complex information into actionable insights for senior leaders/governance forums; strong written and verbal communication.
- Lead the multi-year roadmap for Quality digital capabilities (emphasis on SAP, Veeva, and LIMS).
- Drive prioritization and delivery of Quality capability improvements through governance forums; align scope, risk, and adoption to strengthen GxP compliance, inspection readiness, and end-to-end process effectiveness with IT.
- Own QA/QC digital capabilities (e.g., Veeva, LIMS, SAP, Kneat, DocuSign, Ready Room) to ensure validated, compliant operation and value-driven enhancements with process owners, users, IT, and vendors.
- Translate Quality needs into clear, structured functional and system requirements; bridge Quality and IT (SAP & Veeva Center of Excellence).
- Drive standardization and simplification of Quality processes enabled through SAP/Veeva/LIMS; reduce customization for sustainable global operations.
- Evaluate IT feature/module impacts, determine Quality applicability, and lead adoption where value is demonstrated.
- Support Quality data governance (definitions, standards, traceability, lineage) for audit-ready reporting and reliable trending.
- Support release planning/change control for QA/QC systems; assess impacts to procedures, validation, training, and Quality records.
- Ensure inspection-ready documentation for Quality-owned capabilities aligned with the QMS.
- Guide Quality users/super-users on compliant system/data use; triage and escalate issues.
- Lead periodic reviews of system performance/compliance posture (access/roles, audit trails, data integrity controls, procedural adherence).
- Contribute to validation strategy using Quality Risk Management (risk-based validation).
- Maintain strong knowledge of Veeva Vault Quality, LIMS, and SAP best practices; coordinate end-to-end consistency across Vaults/GxP systems.
- Facilitate governance forums for Quality and TOQ capability requests.
Qualifications:
- Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related.
- 8+ years in Quality (biotech/pharma) with strong GxP Quality data domain knowledge (e.g., Deviations, CAPA, Change Control, Complaints, Materials Quality, Batch Disposition/Market Allocation; metrics).
- 5+ years working with SAP in a Quality context (SAP QM or equivalent) with integrations (LIMS, MES, QMS).
- 7+ years with Veeva Vault Quality (or similar QMS).
- Knowledge of complementary systems (ERP, LIMS, MES).
- Experience with Quality Risk Management (ICH Q9).
- Ability to translate complex information into actionable insights for senior leaders/governance forums; strong written and verbal communication.