Manager, Label Operations
Core
Managing label control activities and GMP compliance for cell therapy manufacturing at a biopharma facility.
Role type
Manager, Label Operations (Cell Therapy Manufacturing)
Builds
Clinical and commercial label issuance and control processes for cell therapy products.
Domain
Biopharmaceuticals / Cell Therapy / cGMP Manufacturing
Required skills
GMP compliance, risk management, team leadership, SOP development, quality metrics, regulatory guidelines, process improvement, stakeholder collaboration, project management, staff development
Preferred skills
None explicitly stated
Technologies
Electronic label issuance and control systems, Microsoft Office
Responsibilities
Lead team to ensure label management aligns with global and regional regulatory requirements; oversee daily activities of the label operations team; manage and motivate team members while cultivating a collaborative environment; identify and address label control compliance issues; coordinate project deliverables to support new drug product launches; develop and maintain quality metrics to monitor compliance; write, review, and update SOPs; perform gap assessments to identify process deficiencies; coach and mentor subordinates in training and professional growth.
Seniority
Manager, hands-on leadership