Role:Quality Assurance Manager

Location: San Diego, CA

Key Duties and Responsibilities:

• Provide focus for the Quality Management System and work closely with all departments and functions to promote processes that ensure consistency, continuous improvement and compliance with quality and business requirements.
  
• Provide support for Quality Systems and maintain the appropriate level of customer service. Has the ability to write clear, coherent internal business communications / reports. Formally presents results of work.
  
• Prepare, host and respond to findings for external client audits.
  
• Non Conformance Reports and monitoring reporting performance and trends.
  
• Problem solve, identification of root cause and implementation / follow up of corrective procedures and preventive actions to ensure timely resolution of such problems.
  
• Ability to perform internal audits as required according to site and global plans.
  
• Use auditing as a proactive tool for improvement as well as compliance and challenge existing practice where appropriate.
  
• Timely completion and follow up through to closure of CAPA actions.
  
• Measuring and monitoring of performance against agreed KPIs.
  
• Collate and share information / data across the site as appropriate through reports and follows up on identified improvement opportunities.
  
• Actively contribute to the success of the overall QA team and the site.
  
• Actively participate and/or drives EU/Global QMS improvements as required
  

Minimum Requirements/Qualifications:

• Bachelors Degree in a Scientific/Technical field (i.e. Chemistry, Biology, or Engineering).
  
• Effective communication skills are required, both written and verbal.
  
• Problem solving skills are required in situations that are not procedurally managed.
  
• Analytical ability is required to make competent decisions based on a review of analytical data
  
• Experience with GLP/ ISO9001 and life sciences industry experience