Associate Director, Clinical Quality and Continuous Improvement

Alnylam Pharmaceuticals is hiring an Associate Director, Clinical Quality and Continuous Improvement. This is a remote position open to candidates in the United States. The role provides strategic QA oversight across clinical development procedures to ensure compliance with GCP requirements, regulatory expectations, and internal quality standards.

The person in this role serves as the primary QA partner across clinical development activities, overseeing process adoption and compliance, contributing to operational process improvements, and leading enterprise and multi-study issue management. They work closely with stakeholders across Development, clinical study teams, and Quality teams to drive sustainable quality outcomes through metrics, trend analysis, and root cause analysis.

What you will do

• Represent QA in operational process improvement initiatives, influencing process design, execution, and compliance to align 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 strategies for new and heavily revised processes.
• Act 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.
• Lead the management, tracking, and documentation of Quality Events (QEs) involving significant quality issues and/or multiple studies to enable consistency across studies.
• Drive 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.
• 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.
• Influence and drive a culture of quality, accountability, and continuous improvement.

What they are looking for

• Bachelor's degree in Life Sciences or a related field required. Advanced degree preferred.
• Continuous improvement certifications (including Lean Sigma, Change Management) preferred.
• Minimum of 8 years of experience in GCP Quality Assurance, Clinical Quality, or GCP-focused roles within the pharmaceutical, biotech, or CRO environment.
• Experience leading enterprise improvement efforts that include application of DMAIC/Lean methods and Change Management techniques preferred.
• 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.

Pay and benefits

The U.S. pay range for this full-time role is $164,500.00 to $222,500.00 per year. Base pay will be determined based on factors including relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).

Alnylam offers medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts, and a 401(k) with a company match. Eligible employees receive paid time off, wellness days, holidays, and two company-wide recharge breaks. The company also offers family resources and leave.

About Alnylam

Alnylam is the leader in RNAi therapeutics, an approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible. The company's core values are fierce innovation, passion for excellence, purposeful urgency, open culture, and commitment to people.

Alnylam commits to an inclusive recruitment process and equal employment opportunity. Qualified applicants receive consideration without regard to sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.