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Clinical QA Manager

  • Location

    San Francisco, California

  • Sector:

    Life Sciences

  • Job type:


  • Salary:


  • Contact:

    Cortland Hotz

  • Contact email:

  • Salary high:


  • Salary low:


  • Published:

    about 1 year ago

  • Expiry date:


  • Startdate:


A fast growing and innovative biopharmaceutical company is looking to hire an experienced Clinical Quality Assurance Manager to join their team.



Position Summary:


This person with work cross functionally with the Clinical Quality and Corporate Quality team. Some of the main responsibilities include:


  • Plans and transforms policies, systems and procedures associated with clinical quality
  • Contributions in external audits
  • Completes internal audits
  • Provides knowledge and leadership to various departments to assure clinical trials are conducted in compliance with Good Clinical Practices (GCP)
  • Assitis Contract Research Organization staff in the proper execution of GCP
  • Works with internal stakeholders in complying with and developing new SOPs
  • Demonstrates the highest level of detail within clinical quality compliance



Key Responsibilities:


Position specific requirements


  • Familiarity in conducting clinical trials
  • Knowledge with internal audits of clinical quality systems
  • Involvement in working with CAPA closure and audit finding remediation
  • Capable of maintaining databases


Other valuable capabilities


  • Familiarity with electronics solutions supporting clinical trials
  • Extensive knowledge of MS Word, Excel, Access, Visio and PowerPoint
  • Proven ability to work cross functionally



Knowledge, Skills and Experience:


  • Minimum 5 years’ experience in Biopharma industry with 5 years’ experience in clinical quality assurance or clinical operations.
  • Bachelor’s degree required, science related field preferred