Virtual Associate Director, Quality Digital Platforms

Alnylam Pharmaceuticals, Inc.

Northern (KY)

Hybrid

USD 170,000 - 210,000

Full time

7 days ago

Be an early applicant

Application generator

Stand out for this role — generate a tailored resume and cover letter in about a minute.

Get past ATS filters

Job summary

Alnylam Pharmaceuticals, Inc. seeks an Associate Director to lead Quality digital capabilities and enterprise systems.

You will translate Quality needs into scalable digital requirements and shape the roadmap for SAP, Veeva, LIMS and related platforms, partnering with IT and governance bodies to ensure compliant, efficient operations. The role emphasizes data integrity, global operations, validation, and change control across QA/QC systems, with a focus on cross-functional collaboration and

Qualifications

Bachelor's degree in Life Sciences, Engineering, Computer Science, or related field.
8+ years of experience in Quality or related areas within biotechnology or pharmaceutical industries with a strong understanding of GxP Quality data domains.
5+ years experience with SAP in a Quality context including SAP Quality Management or equivalent modules and integrations with LIMS, MES, and QMS platforms.
7+ years of experience with Veeva Vault Quality or similar QMS technology.
Knowledge of complementary systems (ERP, LIMS, MES).
Experience with Quality Risk Management (ICH Q9) to drive risk-based decision-making, prioritization, and continuous improvement across GxP processes.
Experience translating complex data into clear, actionable insights for senior leaders and governance forums; strong written and verbal communication skills.

Responsibilities

Lead the development and definition of the multi-year roadmap for Quality digital capabilities, with emphasis on SAP, Veeva and LIMS.
Drive prioritization and delivery of Quality capability improvements through governance forums and stakeholder alignment.
Provide Quality business ownership for QA/QC digital capabilities (e.g., Veeva, LIMS, SAP, Kneat, DocuSign).
Serve as the primary translator between Quality and IT/SAP & Veeva Center of Excellence teams.
Drive standardization and simplification of Quality processes enabled through SAP, Veeva, LIMS, etc.
Evaluate IT system features and modules for applicability to Quality and lead adoption where value is shown.
Support Quality data governance, definitions, standards, traceability, and lineage for metrics and audit-ready reporting.
Support release planning and change control for QA/QC systems, ensuring validation, training and records.
Ensure high-quality, inspection-ready documentation in alignment with QMS.
Provide guidance to Quality users on compliant use of Quality systems and data.
Lead periodic Quality reviews of system performance and compliance posture across QA, IT and functional groups.
Contribute to validation strategy with Quality Risk Management principles.
Maintain strong functional knowledge of Veeva Vault Quality, LIMS and SAP capabilities.
Coordinate with owners of other Veeva Vaults and GxP systems to promote end-to-end process consistency.
Facilitate governance forums for Quality and TOQ capability requests with risk-based decision-making.