Associate Director, Quality Assurance

Alnylam Pharmaceuticals•Cambridge, MA

4d•$164,500 - $222,500•Remote

About The Position

Provides strategic QA oversight across clinical development procedures to ensure compliance with GCP requirements, regulatory expectations, and internal quality standards. Serves as the primary QA partner across clinical development activities by providing oversight of process adoption and compliance, contributing to operational process improvements, and leading enterprise and multi-study issue management. Ensures that quality events, audit and inspection learnings, and regulatory expectations are effectively incorporated into operational processes and study execution. Partners closely with stakeholders across Development, clinical study teams, and Quality teams to drive sustainable quality outcomes through metrics, trend analysis, and root cause analysis, strengthening process effectiveness, enhancing compliance, and enabling consistent issue management across studies.

Requirements

Bachelor’s degree in Life Sciences or related field required.
Minimum of 8 years of experience in GCP Quality Assurance, Clinical Quality, or GCP-focused roles within the pharmaceutical, biotech, or CRO environment.
Strong experience in GCP regulations, inspection readiness, and audit/quality systems
Demonstrated experience in process improvement, quality systems, or operational excellence initiatives.
Experience with root cause analysis, CAPA management, and issue management frameworks.
Proven ability to work across multiple studies/programs and influence cross-functional stakeholders.
Prior experience with quality metrics, data analytics, and compliance metrics to drive decision-making.
Deep knowledge of ICH GCP, FDA, EMA, and global clinical regulatory requirements.
Experience with regulatory inspections and audits (FDA, EMA, or other health authorities).
Ability to influence without direct authority and lead cross-functional initiatives.
Strong analytical, organizational, and communication skills.
Strategic mindset with ability to balance big-picture transformation and operational execution.
Strong analytical and problem-solving skills with ability to identify systemic trends.
Ability to translate data into actionable insights and business decisions.

Nice To Haves

Advanced degree preferred.
Continuous improvement certifications (including Lean Sigma, Change Management) preferred.
Experience leading enterprise improvement efforts that include application of DMAIC/Lean methods and Change Management techniques preferred.

Responsibilities

Represent QA in operational process improvement initiatives, influencing process design, execution, and compliance to ensure alignment with regulatory expectations, organizational strategy, and risk-based quality management principles.
Identify process inefficiencies and implement scalable, standardized solutions to enhance quality system performance.
Partner cross-functionally to embed quality into end-to-end processes.
Provide input into change management strategy(ies) for new and heavily revised processes.
Acts as a subject matter expert in driving scalable quality solutions within continuous improvement activities across clinical and, where applicable, pre-clinical (GLP) and post-market (PV) domains.
Establish and maintain mechanisms to measure process adoption, compliance, and effectiveness following implementation of new or revised processes.
Lead targeted post-implementation oversight activities with process owners and study teams to evaluate alignment between updated procedural requirements and operational execution.
Identify gaps in process understanding or execution and partner with stakeholders to implement sustainable corrective and preventive actions that support effective remediation and sustained adoption.
Lead the management, tracking, and documentation of Quality Events (QEs) involving significant quality issues and/or multiple studies to enable consistency across studies
Drive comprehensive, cross-study issue root cause analysis (RCA) efforts.
Establish and maintain standardized approaches for impact assessment, classification, and resolution of multi-study QEs and QEs that require systemic improvements.
Escalate recurring or systemic trends to Clinical Quality Risk & Portfolio Oversight leadership.
Translate insights from Clinical Quality Risk & Portfolio Oversight into enterprise-level actions for improvement.
Represent QA in cross-functional teams, governance forums, and strategic initiatives to influence process design, execution, and compliance.
Partner with clinical operations, regulatory, and other stakeholders to ensure alignment and compliance.
Provide QA guidance and subject matter expertise on process-related topics, continuous improvements, and methods for monitoring risks to ensure proactive issue escalation and improvements.
Influence and drive a culture of quality, accountability, and continuous improvement.