Manager, Compliance
Core
Leads a team responsible for audit inspection readiness, quality audit policies, and QMS activities to ensure compliance with U.S. and international regulatory requirements for clinical and commercial manufacturing facilities.
Role type
Manager, Quality Assurance Compliance
Builds
Audit readiness, QMS processes, risk management programs, and client contractual agreements
Domain
Biopharma / Pharmaceutical Manufacturing / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk assessment, audit management, CAPA investigations, QMS data management, process mapping, data analysis, regulatory knowledge (cGMPs, FDA, ICH), team leadership, stakeholder collaboration
Preferred skills
Aseptic processing, RABS, isolators, Track Wise, Master Control, ETQ, Visio, Microsoft Office
Technologies
Track Wise, Master Control, ETQ, Visio, Microsoft Office, Excel, PowerPoint
Responsibilities
Manage internal and external audits and regulatory inspections; oversee risk management program implementation; lead complex audit, deviation, and CAPA investigations; manage quality event trend reports and metrics; develop and maintain quality sections of client contractual agreements; coach, mentor, and develop team members; drive departmental process and system improvement initiatives
Seniority
Manager, hands-on leadership
