Connecting linkedin



Sr Director- Quality Assurance

  • Location

    San Francisco

  • Sector:

    Life Sciences

  • Job type:


  • Contact:

    Jack Flaherty

  • Contact email:

  • Salary high:


  • Salary low:


  • Published:

    about 1 year ago

  • Expiry date:


  • Startdate:


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



  • 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