Quality Assurance Director - GCP

Director, Quality Assurance

I am currently partnered with a Global Contract Research Organisation working within Biotechnology, Pharmaceuticals and Medical devices are looking For a Director of Quality Assurance. Acting as a leader in the QA Department, you will assist in overseeing all global QA processes, possessing strong knowledge of global GCP regulations and guidelines.  

Responsibilities

• Manage and lead regulatory inspections including internal, the Sponsor and/or investigator and vendor audits
• Provide leadership and management of the QA Department
• Actively participate in the internal CAPA program, quality data analysis/trending and continuous process improvement initiatives
• Oversee internal process/system audits and external investigative site/ vendor audits
• Conduct and assist in the development of trainings on a company-wide basis
• Provide internal consulting to project-teams as needed; alongside collaborations with external clients and/or Sponsors
• Provide support and leadership in Sponsor audits
• Provide QA representation in project meetings, bid defences and/or Sponsor governance activities, as required

Qualifications

• Bachelor’s degree in Life Sciences
• Past supervisory experience; with expert knowledge of GCP Regulations and Guidelines, National Regulations and EU Directives within member states
• The ideal candidate will have 8+ years of experience in Quality Assurance