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Director, Quality Assurance

Company: Sanaria Inc.
Location: Rockville
Posted on: November 14, 2019

Job Description:

Sanaria is a rapidly growing, diverse, inclusive, multi-cultural, biotechnology company at the cutting edge of vaccine innovation. We are passionate about our goal to eradicate malaria. Sanaria employees are exceptional scientifically, mission-driven, and play a variety of roles in research, product development, manufacturing, clinical trials, and support of these endeavors. We celebrate our diversity and offer a strong benefits package including company paid life and disability insurance, health plans with employee and dependent subsidy, and 401k plan with company match. Sanaria seeks a full-time Director, Quality to join our team. Position Purpose: The Director, Quality will be responsible for further developing and optimizing the quality systems and quality assurance policies, programs and procedures in conformance with US and EMEA's guidelines for GMPs for vaccine manufacturing. This position will work cross functionally with manufacturing, testing, facilities and validation team leads in effectively implementing an inspection readiness program. Essential Duties and Responsibilities:

  • Write, revise and implement QMS standard operating procedures
  • Perform gap analysis of current quality programs and procedure to assess compliance to FDA and EMEA requirements
  • Clinical Product release and COA generation
  • Review and approve deviations, investigations, OOS and CAPA
  • Perform effectiveness checks of CAPA and Change Controls
  • Raw data review for GXP reporting
  • Review and approve Change Controls
  • Perform risk assessments of systems
  • Perform internal audits and external audit
  • Perform GMP training
  • Implement a compliant training and evaluation program
  • Manage and mentor the QA team 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; chemistry, biology, microbiology, pharmacy, biotechnology required; MS preferred. At least 10 years of experience in the pharmaceutical/medical device/diagnostic industry including at least 5 years as team lead or management experience in QA required. To apply, send cover letter with salary requirement and resume to , subject line "Director, Quality." Candidates must have long-term eligibility to work in the US without sponsorship. Sanaria cannot sponsor a visa for this position. Sanaria is an equal opportunity employer. For more information, see our website, .

Keywords: Sanaria Inc., Alexandria , Director, Quality Assurance, Executive , Rockville, Virginia

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