Sanaria
Sanaria

Employment

Sanaria is currently expanding its activities and is accepting inquiries and resumes for the positions listed below. If you are interested in furthering your career with us please send the following information to careers@sanaria.com:

  • Cover letter
  • Resume or CV
  • Salary requirements

Sanaria is an equal opportunity employer.


Director of Quality

The Director of Quality will be responsible for further developing and maintaining the quality system and developing quality assurance policies, programs and procedures for the company's clinical product, a novel malaria vaccine. This position will be responsible for both QA and QC functions and will define processes or improve processes for receiving, manufacturing, packaging, testing and distribution for the clinical vaccine.

Essential Duties and Responsibilities

  • Responsible of daily QA activities and related cGMP compliance
  • Clinical Product release and COA generation
  • Manage deviations, investigations, OOS and CAPA
  • Manage stability program
  • Raw data review for GXP reporting
  • Change Control Management
  • Internal audits and external vendor Audit
  • Responsible for clinical formulation studies
  • Manage QC testing
  • Perform GXP training
  • Oversee equipment validations
  • Oversee assay qualification
  • Work directly with the Senior Management to assure both continuous improvement of the Quality System and provide leadership for the overall Quality Management system
  • Manage 2-5 technical professionals in the quality group

Knowledge and Abilities

  • In depth knowledge of US and EU GMP's
  • In depth knowledge of USP and EP compendium
  • In depth knowledge of aseptic and sterile product quality
  • Prior involvement in establishing quality systems and experience in biologics/vaccines are preferred
  • Strong communication, project management, leadership skills and excellent written and oral English language skills are essential
  • The ability to work in a fast paced environment with multiple and competing priorities is essential
  • Education, Work Experience and/or Licensure
  • Bachelor's degree in a science-related field, required; MS or Ph.D. preferred
  • At least 10 years of experience in the pharmaceutical/medical device/diagnostic industry including at least 5 years or progressive management experience in QA and QC and at least 5 years in a quality role are required. U.S. citizenship or permanent resident status is required

 

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