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NONovartis Radiopharmaceuticals GmbH

Site Quality Head(m/w/x)

Halle (Saale)
Full-timeWith Home OfficeManagement
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Technical and strategic quality leadership for Radioligand Therapy (RLT) drug products, ensuring GxP/cGMP compliance. 10+ years GMP Pharmaceutical Manufacturing experience required. Flexible working schedule, WFH option.

Requirements

  • BS/MSc in Life Sciences or related experience
  • 10+ years GMP Pharmaceutical Manufacturing experience
  • 3 years Quality Control or Quality Assurance experience
  • Experience supporting Quality Control operations
  • Compliance with global cGMP requirements
  • In-depth knowledge of cGMP regulations
  • Successful management of Health Authority inspections
  • Ability to manage complex multiple projects
  • Fluent written and spoken German and English
  • Desirable experience with Health Authorities and inspections

Tasks

  • Provide technical and strategic leadership for quality matters
  • Ensure compliance with GxP and cGMP standards
  • Oversee adherence to the company's Quality Manual
  • Lead strategic site initiatives and cross-functional projects
  • Verify safe and compliant facility and equipment installation
  • Manage validation activities during project planning and construction
  • Escalate risks regarding project timelines and budgets
  • Oversee investigations into product quality deviations
  • Define and analyze Site Quality KPIs
  • Establish and manage the Site Quality Committee
  • Coordinate Site Quality Plans and risk assessments
  • Hire, develop, and retain a high-performing team

Work Experience

  • 10 years

Education

  • Master's degree

Languages

  • German – Business Fluent
  • English – Business Fluent

Tools & Technologies

  • GMP
  • cGMP

Benefits

Competitive Pay

  • Competitive salary

Bonuses & Incentives

  • Annual bonus

Flexible Working

  • Flexible working schedule
  • Work from home possibility

Retirement Plans

  • Pension scheme

Other Benefits

  • Employee Recognition Scheme

Healthcare & Fitness

  • Expanded health promotion program

Job Security

  • Employment at Top SI Employer

Learning & Development

  • Unlimited learning and development
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis Radiopharmaceuticals GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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