Associate Director, Clinical Quality and Continuous Improvement
New
A
AlnylamClinical quality
Source API remote eligibility restrictions: United StatesFull-TimeDirector
Salary$164,500.00 - $222,500.00
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Job Details
- Experience
- Minimum of 8 years of experience in GCP Quality Assurance, Clinical Quality, or GCP-focused roles within the pharmaceutical, biotech, or CRO environment.
- Required Skills
- Process improvement
Requirements
- Bachelor’s degree in Life Sciences or a related field.
- At least 8 years of experience in GCP Quality Assurance, Clinical Quality, or GCP-focused roles in pharmaceutical, biotech, or CRO environments.
- Strong experience with GCP regulations, inspection readiness, and audit and quality systems.
- Demonstrated experience in process improvement, quality systems, or operational excellence initiatives.
- Experience with root cause analysis, CAPA management, and issue management frameworks.
- Knowledge of ICH GCP, FDA, EMA, and global clinical regulatory requirements.
- Experience with regulatory inspections and audits, including FDA, EMA, or other health authorities.
- Experience with quality metrics, data analytics, and compliance metrics to support decision-making.
- Ability to work across multiple studies or programs and influence cross-functional stakeholders.
- Ability to influence without direct authority and lead cross-functional initiatives.
- Advanced degree preferred.
- Experience leading enterprise improvement efforts using DMAIC or Lean methods and Change Management techniques preferred.
- Continuous improvement certifications, including Lean Sigma or Change Management, preferred.
Responsibilities
- Represent QA in operational process improvement initiatives and contribute to process design, execution, and compliance.
- Identify process inefficiencies and implement scalable, standardized solutions to improve quality system performance.
- Partner cross-functionally to embed quality into end-to-end processes and provide input into change management strategies.
- Establish mechanisms to measure process adoption, compliance, and effectiveness after process changes.
- Lead post-implementation oversight with process owners and study teams to assess operational execution against updated procedures.
- Identify process gaps and partner with stakeholders on sustainable corrective and preventive actions.
- Lead tracking and documentation of significant or multi-study Quality Events and drive cross-study root cause analysis.
- Establish standardized approaches for impact assessment, classification, and resolution of multi-study Quality Events.
- Escalate recurring or systemic trends and translate quality insights into enterprise-level improvement actions.
- Represent QA in cross-functional teams and governance forums, providing guidance on process improvement and risk monitoring.
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