San Francisco, California
12 months ago
This opportunity is with a company who are experts in R&D and clinical development of life saving therapeutics. Leading programs in oncology (cell therapy), neurology, gene therapy and inflammatory diseases, with over 13 Phase 3 clinical studies in more than 30 countries.
You will have the freedom to promote a quality focused culture that allows continuous improvement across the functional areas of the business.
Acting as the Deputy QA Director (Associate Director), you will be tasked on your leadership and guidance duties during EMA and FDA health authorities inspections; training programs, responses to regulatory agencies and ensuring the QA team are well prepared for inspections/audits.
Have independence to develop and improve quality management systems for pre-clinical and clinical studies.
Recruit, develop and retain QA professionals, building a world class QA team.
Must be able to investigate and identify any quality related issues to ensure the correct solution is found.
Over 7 year's experience in a in quality assurance role with management experience.
Background in pharmaceutical company
Have experience dealing with EMA and FDA inspections
Worked within Biological Sciences or related field with an education or training in cell culture and gene therapy a plus
ASQ Auditor certification