Job Description:
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.
