Senior Director, Audits, Inspections QMS

Overview

Reporting to the SVP, Head of Quality Assurance & Quality Control, this is an enterprise leadership role and is responsible for providing strategic and operational leadership in the planning and execution of various elements across the Quality Management Systems (QMS). To include all GxP audit programs across research, development, manufacturing, supply chain, regulatory, marketing and commercial, as well as direct oversight of the successful execution of all global, regulatory, GxP inspections.

This role is the owner and decision‑maker administering Alnylam's Quality Management Systems (QMS), inclusive of elements such as deviations, corrective/preventative actions, document control, training, etc.

This individual acts in a capacity such that they represent Alnylam to both external entities and senior internal stakeholders and requires the ability to influence and negotiate complex and time‑sensitive interactions. They are also responsible to ensure and oversee QMS/GxP governance forums and that monitoring activities are in place and are designed to demonstrate the health of Alnylam's quality systems.

• Will maintain and oversee GxP Audit Programs and ensure audit planning is executed at a minimum annually (i.e., annual audit plans).
• Responsible to ensure execution of the GxP audit strategy, in accordance with approved plans, to include both internal (process) audits, external supplier/vendor audits, and external entities such as IRBs, CROs, CMOs, partner audits, Safety Data Exchange Audits, etc.
• This role will also define and provide oversight of the execution of global audit/inspection standards for external entities that audit or inspect Alnylam (e.g., development/marketing partners, regulatory inspections, etc.)
• Leads the response process, inclusive of identifying corrective and preventative actions, and ensures timely submission of regulatory inspection responses.
• Maintains oversight to ensure all regulatory inspection commitments are actioned and completed timely and evidence of actions is available and well organized.
• Is the Quality representative and liaison for all Internal Audit (Finance) and Compliance & Ethics initiatives, interactions and shared work processes.

• Responsible for developing, implementing, and maintaining a robust global GxP quality management system (QMS) applicable to research, development, manufacturing, distribution and commercial activities, aligned with GxP regulations and industry best practices.
• Provide GxP Quality Management System (QMS) process ownership and oversight for Audits & Self Inspections, Document Control & Retention, Training, Good Documentation Practices, Deviation, CAPA, Change Management, Regulatory Intelligence, Translations, etc. and responsible to oversee the execution of the QMS and state of compliance across the enterprise.
• Ensure process, monitoring and governance is in place to ensure compliance with applicable global regulatory requirements and guidelines.
• Responsible to maintain the Global Quality Manual updated, and aligned with global regulatory expectations. Will also ensure all local affiliate Quality Manuals are updated and aligned with the global expectations.
• Responsible to ensure governance forums and mechanisms are in place for all elements of the QMS (e.g., Quality Management Reviews, Quality Risk Management, Issue Escalation, Audits & Self Inspections, Supplier Oversight, etc.) and will provide oversight of those activities.
• Provides oversight of all Quality‑owned processes and training, to include the Quality Policy and Quality Training Curricula. And is responsible to ensure they are maintained up‑to‑date and in a state of compliance, as well as designed to meet current regulatory expectations.
• Leads the Global Document Control Team, owns the enterprise document management processes, and will ensure standards and the document hierarchy are maintained for SOPs, Work Instructions, Forms, Templates, etc.
• Responsible to manage the documentation and workflows within the electronic systems (Veeva) and support business stakeholders enterprise‑wide with use of the system for both GxP and…