临床质量与持续改进总监

Associate Director, Clinical Quality and Continuous Improvement
Overview
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.
This position is open to remote working.
Key Responsibilities
1. Process Improvement & Quality System Enhancement

• 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.

2. Process Adoption Monitoring & Compliance Assurance

• 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.

3. Enterprise/Multi-Study Issue Management

• Lead the management, tracking, and documentation of Quality Events (QEs) involving significant quality issues and/or multiple studiesto 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.
• 4. Quality Leadership & Cross-Functional Collaboration

• 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.

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Qualifications

Education

• Bachelor’s degree in Life Sciences or related field required.

• Advanced degree preferred.

• Continuous improvement certifications (including Lean Sigma, Change Management) preferred.

Experience

• 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).

Knowledge & Skills

• 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.

U.S. Pay Range
$164,500.00 - $222,500.00
The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, 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’s robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including 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 generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.
Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website:
About Alnylam
We are the leader in RNAi therapeutics – a revolutionary 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 and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.
At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their 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.
Originally posted on Himalayas