Manager, QA Compliance
Core
Manage Site Quality Operations, Change Controls, Data Integrity, and Quality Council programs for radiopharmaceutical manufacturing.
Role type
Manager, QA Compliance
Builds
Quality systems and compliance for clinical/commercial manufacturing of radiopharmaceutical therapies
Domain
Biotechnology / Oncology / Radiopharmaceuticals
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP regulations knowledge, Change Control management, CAPA review, Data Integrity leadership, Quality metrics development, Cross-functional stakeholder collaboration, Laboratory safety compliance
Preferred skills
Clinical/commercial manufacturing QA experience, US/EU regulatory knowledge, AI application for team execution
Technologies
None explicitly stated
Responsibilities
Implement and manage Change Control Quality System, Run Change Control Review Boards, Lead site Data Integrity Program, Manage complaints and investigations, Develop and maintain Quality Metrics, Participate in health authority inspections
Seniority
Manager, hands-on IC
