Manager, Clinical Quality Services
Core
Manage clinical quality activities, team performance, and compliance for a Clinical Customer Focused Team in a biopharma contract manufacturing environment.
Role type
Manager, Clinical Quality Services
Builds
Quality product/service delivery for biopharma clients
Domain
Biopharma / Contract Manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Team supervision and development, Quality team goal setting, Cross-functional collaboration, Daily team performance facilitation, Training and onboarding management, Customer audit and complaint investigation support, Performance metrics management, Corrective and preventive maintenance coordination, Calibration activity management, Qualification and validation activity management
Preferred skills
Project management
Technologies
Computer programs for complex tasks
Responsibilities
Supervise, coach, and develop a team of Quality Specialists and Inspectors; Establish quality team goals aligned with customer requirements; Facilitate daily team performance and build a culture of safety and continuous improvement; Manage training, cross-training, and onboarding; Support customer audits, visits, and deviation investigations; Manage team performance metrics and customer scorecards; Coordinate Quarterly Business Reviews (QBRs); Manage corrective and preventive maintenance activities; Oversee calibration activities and OOS investigations; Manage qualification and validation activities including temperature mapping and change control.
Seniority
Manager, supervisory role