Supervisor, Document Control
Core
Oversee daily operations of the Document Control department to ensure accuracy, integrity, and compliance of controlled documentation within the organization's Quality Management System (QMS).
Role type
Supervisor, Document Control
Builds
Controlled documentation lifecycle (creation, review, approval, revision, distribution, archival, retirement) and EDMS integrity
Domain
Life Sciences / Pharmaceutical / Medical Device / Manufacturing
Required skills
Supervisory leadership, document lifecycle management, QMS administration, EDMS administration, regulatory compliance monitoring, audit support, change control management, CAPA management, staff training and mentoring, process improvement, reporting
Preferred skills
Pharmaceutical/biotech/manufacturing environment experience, FDA/ISO inspection support, project management
Technologies
MasterControl, Veeva, TrackWise Digital, OpenText, SharePoint, Microsoft Office
Responsibilities
Supervise the daily activities of the Document Control team, Manage the document lifecycle including creation to retirement, Administer and maintain the Electronic Document Management System (EDMS), Ensure compliance with GDP, GMP, FDA regulations, and ISO standards, Lead document control investigations, Change Controls, and CAPAs, Train and develop Document Control staff, Prepare reports and present document control metrics to management
Seniority
Mid-Senior, hands-on IC with supervisory duties
