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Job

Sr Director- Quality Assurance

  • Location

    San Francisco

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Jack Flaherty

  • Contact email:

    j.flaherty@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    about 2 months ago

  • Expiry date:

    2020-03-11

  • Startdate:

    ASAP

The Quality Assurance US Senior Director is part of the Global Quality Executive Team and is accountable for QA at the California facilities and for US commercial operations.

Main tasks:

  • Ensure Regulatory and Compliance at  sites
  • Quality Assurance for Pharmacovigilance
  • Quality operations support for new therapeutic development areas (Oncology, Localized application)
  • QA for US market feedback- and local complaint management
  • Drive US inspection readiness activities at sites
  • Host Health Authority Inspections
  • Quality business partner to key stakeholders (RA, Clinical, Pharmacovigilance, Commercial)
  • Provide input to the Global Quality Management Review
  • GMP, GDP, GPVP Training

 

Requirements

  • Experience in GxP, Quality Systems and Regulatory Compliance, Health Authority Inspections, Pharmacovigilance, Complaints, etc.
  • Experience in Product Development and with Commercial products
  • Demonstrated Leadership within and across functions/teams

Knowledge, Skills and Experience

  • Minimum 14 years’ experience in Biopharma industry with min. of 10 years’ experience in Quality Management and Quality Assurance
  • Minimum of 8 years leadership experience
  • Managing roles at Authority Inspections, Quality Systems and reporting, and Regulatory Compliance
  • Master´s degree Preferred, science related field preferred