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

Job

Sr Director- Quality Assurance

Requirements