QA Manager

We are looking to hire a Quality Assurance Manager to who will lead QA activities in the US.  

Some Responsibilities

• Initiates and executes internal, site and vendor audits and assessments to assess quality standards, and creates Annual Audit Program 
• Provides QA advice on complex procedures to Clinical staff 
• Performs quality review of QMS documents 
• Responsible for testing and assessing the quality objectives 
• Identifies need for project-specific QAMPs, creates, maintains and executes QAMPs and coordinates updates of QAMPs 
• Mentor for new QA staff 
• Identifies improvement possibilities for continuous development of Julius clinical and initiates and executes project teams working on improvements to processes
• Initiates and executes implementation of new regulations within company
• Collects and interprets data on quality of study conduct and identifies points that require improvement on the basis of the data; Initiates and creates annual department reports  
• Is responsible for the application of new quality technologies and methods 
• Coordinates and hosts sponsor audits and regulatory inspections 
• Coordinates and maintains the CAPA Program 
• Assists Global Director Quality Management 

Requirements 

• Bachelor’s degree in a science, technology, or related field
• Extensive knowledge of legislation and regulations, clinical processes, industry practices and ICH-GCP guidelines  
• 7+ years' experience in a relevant function in clinical research, or a minimum of 5 years’ experience in QA 
• Ability to adjust priorities as needed in a growing global CRO
• Outstanding communication skills