ppWe 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. /p pIn 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 to work at the interface of development, manufacturing, and external partnerships in a global, matrixed organisation. /p h3Roles and Responsibilities /h3 ul liProvide QA oversight for new product introduction (NPI) activities, ensuring compliance with GMP and regulatory requirements. /li liLead QA support for technology transfer to CMOs, including review and approval of protocols and risk assessments. /li liEnsure external manufacturing sites are inspection‑ready and compliant. /li liAct as QA lead for external manufacturing partners, ensuring adherence to quality standards and agreements. /li liReview and approve GMP documentation including batch records, deviations, CAPAs, and validation reports. /li liMonitor CMO performance through quality metrics, audits, and governance processes. /li liProvide QA oversight for manufacture of investigational medicinal products (IMPs) supporting clinical trials. /li liSupport supply of products to pharmaceutical partners for clinical studies. /li liAct as QA interface during client audits and health authority inspections. /li liPartner with global cross‑functional teams to deliver NPI programs. /li liContribute to project governance, risk management,



and decision‑making. /li liReview documentation ensuring it is clear, accurate, and inspection‑ready. /li liApply Quality Risk Management (QRM) principles to mitigate risks. /li liSupport deviation management and CAPA implementation. /li liDrive continuous improvement of NPI and external manufacturing quality processes. /li liConduct on‑site visits to CMOs to support technology transfer and QA oversight. /li /ul h3Required Qualifications /h3 ul liBachelor’s degree in Life Sciences, Pharmacy, Chemistry, or related discipline. /li liExperience in Quality Assurance within a GMP‑regulated environment. /li liExperience in NPI, technology transfer, validation, or external manufacturing. /li liExperience working with Contract Manufacturing Organizations (CMOs). /li liKnowledge of global regulatory requirements (FDA, EMA, ICH). /li /ul h3Desired Characteristics /h3 ul liAbility to work in a global, cross‑functional matrix environment. /li liStrong stakeholder management and influencing skills. /li liSolid understanding of GMP and quality systems. /li liStrong problem‑solving and risk‑based decision‑making skills. /li liExcellent written and verbal communication skills. /li liHigh attention to detail and strong compliance mindset. /li /ul h3Additional Information /h3 pThis role requires travel (approximately 10–25%) to support external manufacturing activities, audits, and technology transfer. /p pRelocation Assistance Provided: No /p h3Inclusion and Diversity /h3 pGE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. /p /p #J-18808-Ljbffr

📌 QA Specialist - NPI (Turbigo)
🏢 Ge Healthcare
📍 Turbigo