Regulatory Affairs Manager III

• Develops, maintains, and executes vendor oversight activities for assigned trials / indications to ensure quality in the execution of clinical trials, compliance with regulatory requirements and SOPs, and to ensure a continued state of inspection readiness. 
• Monitors risks and mitigation during study execution. 
• Prepares periodic reports assessing critical to quality parameters. 
• Responds independently to GCP-related compliance inquiries from clinical team members and other departments on an ongoing basis.
•  Liaises with other members of Quality, as appropriate, to ensure alignment and consistency with guidance provided. 
• Develops and executes strategy to ensure inspection readiness for the vendor space, and provides support during sponsor-monitor inspections, as needed. 
• Manages escalation of significant quality issues per company policy and SOPs and in collaboration with stakeholders to ensure timely issue resolution. 
• Consults with appropriate business partners and peers within Quality to develop and implement CAPAs.
• Critical skills needed to perform the job include enterprise leadership and facilitation, collaboration, attention to detail, significant experience and demonstrated business acumen, project management, communication, process management, and team performance management.
• Making the complex simple and representing a true enterprise view are critical competencies. 

Additional Responsibilities Include

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• Consults independently on questions related to research quality and compliance from other departments and confers with other team staff, and other colleagues as needed, to ensure consistent interpretation of international regulations and policy. 
  

• Participates in cross-functional or cross sector working groups to develop or refine processes, tools, and systems that support key activities. 
  
• Trains or mentor's peers and new staff as needed.