QA Specialist - NPI

We are seeking a Lead QA Specialist - New Product Implementation to provide Quality Assurance leadership for the introduction of new products across a global external manufacturing network. In this role, you will lead QA oversight of technology transfer to Contract Manufacturing Organizations (CMOs) and support external partners manufacturing products for GE HealthCare-sponsored clinical trials and pharmaceutical partner studies. You will work in a highly collaborative, cross-functional environment, ensuring compliant, right-first-time delivery of new product introductions. This is an excellent opportunity for an experienced QA professional to work at the interface of development, manufacturing, and external partnerships in a global, matrixed organisation.,

• 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., This role requires travel (approximately 10-25%) to support external manufacturing activities, audits, and technology transfer.
  
  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