Lead QA Specialist – New Product Implementation
Core
Lead QA oversight for new product introduction (NPI) and technology transfer to Contract Manufacturing Organizations (CMOs) for clinical trials and pharmaceutical studies.
Role type
Senior IC Quality Assurance Specialist (NPI & Technology Transfer)
Builds
Compliant new product introductions and investigational medicinal products for clinical trials
Domain
Medical technology / Radiopharmaceuticals / GMP-regulated manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, technology transfer, validation, CMO management, regulatory knowledge (FDA/EMA/ICH), QRM, deviation management, CAPA, batch release, audit support
Preferred skills
Radiopharmaceutical industry experience, global matrix environment navigation, stakeholder influencing, risk-based decision-making
Technologies
QMS, GMP documentation systems
Responsibilities
Provide QA oversight for NPI activities ensuring GMP compliance; Lead QA support for technology transfer to CMOs including protocol review; Ensure external manufacturing sites are inspection-ready; Review and approve GMP documentation (batch records, deviations, CAPAs, validation reports); Monitor CMO performance via quality metrics and audits; Act as QA interface during client audits and health authority inspections; Conduct on-site visits to CMOs for technology transfer and oversight; Support supply of products to pharmaceutical partners for clinical studies.
Seniority
Senior, hands-on IC