Sr Manager Regulatory Surveillance

Sr Manager For Regulatory Surveillance

The Sr Manager for regulatory surveillance will support the regulatory surveillance and intelligence process as well as the inspection readiness process. The position must work cross-functionally across the organization and have excellent communication and collaboration skills. Responsibilities:

• Responsible for triaging and assessing regulatory surveillance items such as new regulations or guidance.
• Leads cross-functional teams to assess the impact of these regulations to the Vertex organization and associated quality systems and processes.
• Provide guidance and expertise to the team on regulatory expectations, standard practices in the industry, and options for implementation.
• Supports inspection and submission readiness by tracking and reporting progress on various metrics and programs.
• Reports out on KPIs and metrics to communicate status and risks.

Requirements:

• Bachelor's degree in a scientific discipline, operations research, operations management, or a related field.
• Typically requires 6 years of relevant experience or the equivalent combination of education and experience.
• Superb facilitation, organization, communication, and influencing skills with proven ability to lead teams.
• Excellent knowledge of global GMP requirements and regulations.
• Ability to evaluate quality matters and make decisions utilizing risk-based approach.
• Proven ability to identify and analyze performance indicators.
• Strong technical knowledge including but not limited to: regulatory, inspections, and compliance.