Associate Director, Clinical Quality and Continuous Improvement
New
A
AlnylamBiotechnology
United StatesFull-TimeManager
Salary$164,500.00 - $222,500.00
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Job Details
- Experience
- Minimum of 8 years
- Required Skills
- GCPQuality AssuranceChange ManagementData analytics
Requirements
- Bachelor’s degree in Life Sciences or related field required; advanced degree preferred.
- 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.
- Deep knowledge of ICH GCP, FDA, EMA, and global clinical regulatory requirements.
- Proven experience with root cause analysis, CAPA management, and issue management frameworks.
- Demonstrated experience in process improvement, quality systems, or operational excellence initiatives.
- Ability to influence without direct authority and lead cross-functional initiatives.
- Experience with regulatory inspections and audits (FDA, EMA, or other health authorities).
- Strong analytical and data-driven decision-making skills.
- Continuous improvement certifications (including Lean Sigma, Change Management) preferred.
- Experience leading enterprise improvement efforts utilizing DMAIC/Lean methods preferred.
Responsibilities
- Represent QA in operational process improvement initiatives to ensure alignment with regulatory expectations and risk-based quality management.
- Identify process inefficiencies and implement scalable solutions to enhance quality system performance.
- Monitor process adoption and compliance following the implementation of new or revised procedures.
- Lead the management, tracking, and documentation of Quality Events and multi-study issue resolution.
- Drive comprehensive, cross-study issue root cause analysis efforts and facilitate systemic improvements.
- Partner cross-functionally with clinical operations and regulatory teams to ensure consistent quality and compliance.
- Translate data and metrics into actionable insights to drive enterprise-level improvements.
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