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SENIOR DIRECTOR, CQA

  • Job type: Permanent
  • Location: District of Columbia
  • Salary: $180000 - $220000 per annum
  • Job reference: MERZ
  • Sector: Quality Assurance, EPM Scientific, Quality
  • Date posted: 18/10/2017
SENIOR DIRECTOR/DIRECTOR, CLINICAL QUALITY ASSURANCE
  • Multi-Million Clinical Stage Vaccine Company
  • Washington, DC
  • $180,000 - $220,000 + Bonus + Benefits + Career Growth

A global biotechnology company is looking to hire a SENIOR DIRECTOR/DIRECTOR, CLINICAL QA to join the team! This company is one of the world leaders committed to manufacturing, developing, and distributing high-quality recombinant vaccines! This biotechnology company is family oriented, has a great work-life culture, and has been expanding in size! They offer a competitive base salary, bonus, benefits, and professional career growth!


The Sr. Director/Director, Clinical Quality Assurance will work closely with Quality Assurance, Clinical Operations, Regulatory Affairs, and Pharmacovigilance departments and the Chief Medical Officer in order to provide leadership to implement, develop, and maintain standards and quality systems to make sure that this company is compliant with Good Clinical Practice (GCP) and Good Laboratory Practice (GLP). This role will ensure that all clinical processes and nonclinical activities are maintained within the regulations and guidelines.


The Sr. Director/Director, Clinical Quality Assurance will be responsible for the following activities:
  • Implement, develop, maintain, monitor and improve the clinical quality assurance system and function.
  • Ensure that the auditing functions are in place and well executive in order to address company requirements of subcontractor/vendor audits (clinical and nonclinical), nonclinical data, global clinical investigator site audits, internal and external databases (safety databases and clinical studies), and clinical immunology laboratory audits (internal and external key deliverables/study components).
  • Approve and review qualification reports, development reports, validation protocols, amendments, reports, change controls, nonclinical protocols and reports, CAPAs, and deviations
  • Assure that the execution of GxP operations are compliant with applicable regulations and guidelines through risk assessments and quality risk management.
  • Support regulatory inspections which includes contributing to the conduct, preparation, and responses to regulatory agencies

The Sr. Director/Director, Clinical QA will have the following qualifications:
  • 10+ Years experience in a supervisory experience
  • 15+ Years experience in Clinical Quality Assurance
  • BS/MS within the science field
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