Senior Quality Assurance Specialist

Senior Quality Specialist

The client is a clinical-stage gene therapy company, focused on developing curative treatments for patients living with serious diseases. They pride their team holding a deep expertise in gene therapy development, which allows them to efficiently advance their programs from preclinical to clinical development.

They hold a state-of-the-art manufacturing facility, which is designed to meet all global regulatory requirements, enabling them to have the capacity and flexibility to produce the necessary products for all clinical trials. With their rapidly expanding business, they are looking for a Senior Quality Specialist to join their team.

The main duties include:

• Providing QA support and oversight, ensuring QA regulatory compliance and product quality requirements are always met, as well as facilitating product release in a timely manner
• Coach and train the QA team and continuously improve the local Quality
• Create Standard Operating Procedures, Policies and Training material.
• Review Batch documentation
• Provide direct quality team support during customer and regulatory audits
• Perform internal audits, inspections and audit write ups
• Managing Quality Systems: Complete Reporting, reviewing, and investigating, root cause analysis, assessing Quality risk assessments, Incidents, Deviations, CAPA's, Change Controls and Temperature excursions
• Experience under GCP

The company offer a competitive salary, stock options plus great benefits.

If you have a strong quality background and are interested in developing your skills and knowledge do not hesitate to apply now!