Regulatory Intelligence, Quality Senior Manager (Contract) 28047

Atrium Works • Boston, MA

1d • $80 - $85

About The Position

The Sr Manager for regulatory intelligence 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.

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

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.

What This Job Offers

• Career Level: Manager