QA Specialist - NPI

Experteer Overview

In this role you lead QA for the introduction of new products across a global manufacturing network, ensuring compliant and right-first-time delivery. You will oversee technology transfer to CMOs and support external partners manufacturing products for clinical studies, partnering with cross-functional teams to enable successful NPI programs. You drive quality governance, risk management, and inspection readiness across external sites. This position offers impact at the interface of development, manufacturing, and external partnerships within a matrixed, global environment.

Retribuzione / Benefits

• QA oversight for new product introduction activities ensuring GMP/regulatory compliance
• Lead QA support for technology transfer to CMOs including review of protocols and risk assessments
• Ensure external manufacturing sites are inspection-ready and compliant
• Act as QA lead for external manufacturing partners
• Review and approve GMP documentation (batch records, deviations, CAPAs, validation reports)
• Monitor CMO performance via quality metrics, audits, governance
• QA oversight for manufacture of IMPs for clinical trials and support for pharmaceutical partners
• 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 for clarity, accuracy, and inspection readiness
• Apply Quality Risk Management 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 transfer and QA oversight

Responsabilità

• 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 CMOs
• Knowledge of global regulatory requirements (FDA, EMA, ICH)