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Novartis
last mo.

Site Quality Head(m/w/x)

Basel
Full-timeWith Home OfficeSenior

Description

As the Site Quality Head, you will lead efforts to uphold world-class quality and compliance at a strategic manufacturing site, ensuring adherence to regulatory standards while fostering a culture of continuous improvement and collaboration.

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Requirements

  • 10–15 years of experience in the pharmaceutical or chemical industry
  • University degree in Chemistry, Pharmacy, or related discipline
  • Strong knowledge of regulatory requirements and cGMP standards
  • Experience with FDA/Swissmedic regulations and compliance
  • Dynamic, resilient, and versatile approach to problem-solving
  • Demonstrated people leadership and team management skills
  • Excellent communication skills and ability to collaborate across functions
  • Fluency in German and English

Education

Bachelor's degree

Work Experience

10 - 15 years

Tasks

  • Lead the Site Quality organization
  • Foster a culture of compliance and continuous improvement
  • Ensure adherence to cGMP and regulatory requirements
  • Act as Qualified Person for site operations
  • Oversee quality governance across all GxP functions
  • Ensure robust risk management
  • Approve or reject raw materials, facilities, utilities, and finished products
  • Drive execution of training programs
  • Maintain compliance with DI and eCompliance standards
  • Manage internal and external audits and inspections
  • Handle regulatory submissions
  • Ensure effective complaint investigations
  • Manage exception processes

Languages

GermanBusiness Fluent

EnglishBusiness Fluent

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