Lead oversight of business unit controlled documents within the Quality Management System to ensure alignment with Thermo Fisher Scientific quality requirements
Serve as Controlled Document Liaison (CDL), track periodic reviews, coordinate SME contributions, author select documents, conduct technical review and lead change control activities
Identify and implement process improvements to strengthen document control
Lead development and implementation of Evidera AI policy and guiding principles, maintain policies and assess needs going forward
Implement AI technology-enabled solutions to improve document management and compliance efficiency
Manage vendor oversight activities, including onboarding, qualification, audits, performance monitoring, vendor quality events and KPI tracking
Oversee strategic computer system applications, supporting onboarding, oversight, audits and compliance
Lead and support internal, client, and regulatory audits
Review and approve audit reports and remediation plans
Identify and resolve quality and compliance risks impacting clinical research programs
Provide reporting, escalation management, and compliance visibility to leadership
Drive Practical Process Improvement (PPI) initiatives to enhance efficiency and reduce operational burden

Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in compliance management, document control, or related field in a multinational company
Extensive knowledge of GxP regulations, document control processes, and quality management systems
Expert knowledge of SOPs and WPDs, including experience managing controlled documents in a Quality Document Management system
Strong understanding of vendor management processes and oversight requirements
Advanced knowledge of computer system validation and compliance requirements
Experience managing technology vendors (applications), acting as business owner and tracking performance
Demonstrated ability to lead AI policy development and implement technology solutions in a regulated environment
Experience using and/or developing AI technologies to drive innovation and efficiency in clinical trial research
Experience with AI strategy and application in research, ensuring compliance with GCP and regulatory standards
Experience in conducting audits, managing CAPAs, and implementing corrective actions
Expertise in quality management systems and regulatory frameworks (GMP, GCP, etc.)
Proven track record in project management and cross-functional team leadership

Quality Documents & Vendor Application Compliance Manager

Key skills