Senior Manager, Manufacturing Technical Services
Core
Develop and execute quality-record strategy for Cell and Gene Therapy (CGT) manufacturing, overseeing CAPAs, change controls, deviations, and analytical investigations.
Role type
Senior Manager, Manufacturing Technical Operations
Builds
Quality event center of excellence for CGT manufacturing
Domain
Biopharmaceutical manufacturing / Cell and Gene Therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP knowledge, complex project management, cross-functional stakeholder management, analytical problem-solving, strategic oversight, team leadership, GMP compliance, data-driven decision making
Preferred skills
Cell and gene therapy manufacturing experience, leading complex investigations, CAPA/change control expertise
Technologies
GMP systems, quality management systems
Responsibilities
Lead and develop a high-performing team of five or more; Provide strategic oversight for complex CAPA and change-control records; Lead cross-functional investigations for major deviations; Establish and promote best practices for quality-event management; Monitor quality-event performance metrics; Drive continuous improvement of site practices; Support inspection readiness.
Seniority
Senior, hands-on IC with management responsibilities
