Clinical QA Associate Director

   
The Clinical QA Associate Director is responsible for  clinical quality assurance functions, and works
closely with Clinical & Medical Affairs, Science and CMC teams, and QA
consultants, to ensure continuous quality improvement. 
Ensures planning, coordination, oversight, and continuous improvement of processes and methods, to control the quality of
studies sponsored by us. 
Oversees continuous improvement projects, and ensures adherence to regulatory authorities’ requirements, ICH-GCP,
Industry Guidelines, along with ower policies and procedures for the conduct of clinical trials. 
Reports to the CEO. 
  Essential Duties and Responsibilities:  
· Develop and maintain GCP-compliant
processes and Procedural Documents, to control the quality of clinical trials sponsored
by us 
· Conduct quality audits, to ensure studies are performed according to GCP, regulatory requirements,
Galmed’s SOPs, and study protocol and requirements. 
· Support the vendors
selection process. 
· Lead or assist with
identifying (internal and vendor) non-conformances, including Root Cause
Analysis & Corrective and Preventive Actions. 
· Support ongoing management
of the clinical studies and ensure inspection readiness. 
· Provide suitable
recommendations and facilitate ongoing quality improvements using risk-based
methodology. 
· Assist with internal training. 
Skills/Qualifications:  
· At least 5 years of experience in Clinical QA in a pharmaceutical company. 
· Strong analytical, problem-solving skills.  
· Strong English written and verbal communication skills.  
· Detail-oriented, good organizational traits.  
· Self-motivated, with strong leadership abilities. 
· Must be results-oriented, multi-tasking, quick learner, respond to the team’s urgent needs and show a
strong track record of meeting deadlines.