Associate Director CMC Regulatory Affairs - Quality Compliance - Quality Compliance
Core
Provide strategic quality compliance leadership and guide regulatory impact assessments for CMC manufacturing and supply operations.
Role type
Senior IC Associate Director, Quality Compliance (CMC Regulatory Affairs)
Builds
Manufacturing and supply business area quality compliance framework
Domain
Biotechnology / Pharmaceutical / CMC Regulatory Affairs
Required skills
Quality Management Systems, Regulatory Impact Assessments, CMC Regulatory Affairs, Team Leadership, Process Improvement, Inspection Readiness, Deviation Management, Corrective and Preventive Action (CAPA), Cross-functional Collaboration, Strategic Alignment
Preferred skills
Managing direct reports, Analyzing complex information, Presenting to stakeholders, Working in ambiguous environments
Technologies
Quality Management Systems, Regulatory Impact Assessment Tools
Responsibilities
Support management of the Quality Compliance group, Champion consistent regulatory impact assessments, Assess changes and deviations within the IOPS Quality Management System, Drive Corrective and Preventive Action plan ownership, Represent Quality Compliance at regulatory and cross-functional meetings, Lead process improvements and inspection readiness initiatives
Seniority
Senior, hands-on IC with management responsibilities
