Director, Commercial Quality-Packaging and Labeling
Core
Operational leadership for commercial resupply and lifecycle management of primary and secondary packaging and labeling across a global CMO network, ensuring compliant and reliable supply.
Role type
Senior Director, Quality Operations (Packaging & Labeling)
Builds
Efficient operating model for packaging and labeling quality across US and UK/EU CMO portfolios
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
Strategic planning, risk-based quality oversight, team leadership, cross-functional stakeholder management, GMP/GDP compliance, operational excellence, change control, audit readiness, data analytics
Preferred skills
None stated
Technologies
None stated
Responsibilities
Lead operational quality oversight for commercial resupply and lifecycle management of packaging and labeling; Translate strategy into operational quality plans and execution expectations; Lead prioritization and decision-making for operational quality issues; Act as primary escalation leader for significant quality issues; Lead cross-functional forums for packaging and labeling quality; Ensure procedural oversight of exemption management, QP activities, and batch documentation; Monitor and trend operational quality metrics and KPIs; Build and maintain effective relationships with CMO Leadership and Qualified Persons; Partner with senior QA leadership on organization design and capability-building; Drive clarity of roles and decision rights across the team
Seniority
Director, hands-on leadership
