QA Specialist - NPI (m/f/d)

Your Profile:

• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or related discipline
  
• Experience in Quality Assurance within a GMP-regulated environment
  
• Experience in NPI, technology transfer, validation, or external manufacturing
  
• Experience working with Contract Manufacturing Organizations (CMOs)
  
• Knowledge of global regulatory requirements (FDA, EMA, ICH)
  
• Ability to work in a global, cross-functional matrix environment
  
• Strong stakeholder management and influencing skills
  
• Solid understanding of GMP and quality systems
  
• Strong problem-solving and risk-based decision-making skills
  
• Excellent written and verbal communication skills
  
• High attention to detail and strong compliance mindset

Your Tasks:

• Provide QA oversight for new product introduction (NPI) activities, ensuring compliance with GMP and regulatory requirements.
  
• Lead QA support for technology transfer to CMOs, including review and approval of protocols and risk assessments.
  
• Ensure external manufacturing sites are inspection-ready and compliant.
  
• Act as QA lead for external manufacturing partners, ensuring adherence to quality standards and agreements.
  
• Review and approve GMP documentation including batch records, deviations, CAPAs, and validation reports.
  
• Monitor CMO performance through quality metrics, audits, and governance processes.
  
• Provide QA oversight for manufacture of investigational medicinal products (IMPs) supporting clinical trials.
  
• Support supply of products to pharmaceutical partners for clinical studies.
  
• Act as QA interface during client audits and health authority inspections.
  
• Partner with global cross-functional teams to deliver NPI programs.
  
• Contribute to project governance, risk management, and decision-making.
  
• Review documentation ensuring it is clear, accurate, and inspection-ready.
  
• Apply Quality Risk Management (QRM) principles to mitigate risks.
  
• Support deviation management and CAPA implementation.
  
• Drive continuous improvement of NPI and external manufacturing quality processes.
  
• Conduct on-site visits to CMOs to support technology transfer and QA oversight.

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