Associate Director, Quality Assurance

Associate Director/Director

Quality Assurance

Cyteir Therapeutics seeks a skilled and motivated Quality professional to join the Quality team to coordinate and oversee the Vendor Management Program. The position will report to the Head of Quality and will be a key contributor to the development and execution of the Vendor Management Program. Candidate will also assist with document control, CAPAs, Investigations and Deviations for all GxP Vendors. Work closely with CMC and Clinical Operations to ensure that all clinical and potential commercial vendors are in state of compliance

Job Responsibilities:

  • Develop, implement and maintain the GxP audit program
  • Develop vendor audit schedule
  • Conduct vendor audits and write audit reports
  • Work closely with CMC to evaluate and implement new vendors
  • Work closely with Clinical Operations to maintain Clinical Vendor Program
  • Ensure that Vendor Program is state of audit readiness
  • Implement electronic audit software

Job Qualifications:

  • Bachelor’s degree in life sciences with a minimum of 7-10 years of relevant hands-on experience in quality assurance
  • Experience in all aspect of clinical development Process (Phase 1 – III)
  • Experience with ensuring that clinical vendors are ready for commercial manufacturing
  • Experience with conducting mock PAIs
  • Detail-oriented, self-motivated team player, with the ability to work independently
  • Ability to communicate clearly and decisively in an open, timely manner
  • A sense of adventure and excitement to help build a successful company and work in a highly dynamic team environment

Associate Director, Quality Assurance