Connecting linkedin

W1siziisimnvbxbpbgvkx3rozw1lx2fzc2v0cy9oyw1sew4td2lsbglhbxmvanbnl2jhbm5lci1kzwzhdwx0lwpvyi5qcgcixv0

Job

Clinical QA Manager

  • Location

    San Francisco, California

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    Competitive

  • Contact:

    Cortland Hotz

  • Contact email:

    c.hotz@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    9 months ago

  • Expiry date:

    2020-03-01

  • Startdate:

    ASAP

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