Hello
Job : Sr. Quality Manager, Regulatory Surveillance
Location : hybrid in Boston, MA need local only with Dl
Client : Vertex
Job Description
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 KPIs and metrics to communicate status and risks
Quality Sr. Manager – Reg Surveillance
General / Position Summary
The Sr. Manager for Regulatory Surveillance supports the regulatory surveillance and intelligence process, as well as the inspection readiness process. This role works cross-functionally across the organization to ensure compliance and requires excellent communication and collaboration skills to achieve company quality objectives.
Key Duties & Responsibilities
Regulatory Triage: Responsible for triaging and assessing regulatory surveillance items, such as new regulations or guidance documents.
Impact Assessment: Leads cross-functional teams to assess the impact of new regulations on the organization’s quality systems and processes.
Subject Matter Expertise: Provides guidance and expertise to teams regarding regulatory expectations, industry standard practices, and implementation options.
Inspection Readiness: Supports inspection and submission readiness by tracking and reporting progress on various metrics and programs.
KPI Management: Reports on Key Performance Indicators (KPIs) and metrics to communicate status, trends, and potential risks to leadership.
Education & Experience
Required Education: Bachelor’s degree in a scientific discipline, operations research, operations management, or a related field.
Required Experience: Typically requires 6 years of relevant experience or the equivalent combination of education and experience.
Required Knowledge & Skills
Leadership: Superb facilitation, organization, communication, and influencing skills with a proven ability to lead cross-functional teams.
Regulatory Expertise: Excellent knowledge of global GMP (Good Manufacturing Practice) requirements and regulations.
Risk Management: Ability to evaluate quality matters and make critical decisions utilizing a risk-based approach.
Data Analysis: Proven ability to identify, analyze, and interpret performance indicators and quality metrics.
Technical Proficiency: Strong technical knowledge in regulatory affairs, inspections, and corporate compliance.
Best Regards,
Mayank Sharma
Sr. Technical Recruiter| Anvik Technologies | Wilmington, DE
📧 Mayank.sharma@anviktek.com
