Director of Quality

Title: Director, Quality Systems and Compliance

Reports to: Vice President of Quality

Location: Framingham, MA

Position Overview

The Director, Quality Systems and Compliance is responsible for establishing and implementing procedures and processes to ensure inspection readiness and the surveillance of GxP compliance at client end. This role ensures that systems and records are compliant with global regulatory requirements.

Job Description

• Direction and oversight for Internal and External audit program, including standards, and routine reporting of progress to plan
• Direction and oversight for the GxP Contract Organization Qualification Program
• Develop metrics and reporting systems for Compliance risk identification and remediation.
• Perform training on global compliance standards, communicating industry trends and enforcement activities
• Leads Clients and Contract Organization Inspection Readiness
• Manages Clients electronic Quality Management System, including oversight of Document Control, Training, Deviations, CAPA program, Change Control and Audit program.
• Leads Quality Management Review, including preparation activities and tracking of action items to closure.
• Ability to travel domestically and internationally up to 15%

Required Skills

• Knowledge of CMC requirements.
• Strong knowledge of global GxP expectations and ICH requirements
• Experience in authorship or review of CMC and/or clinical regulatory submissions.
• Experience in Phase III drug development GxP environment and commercial operations.
• Excellent collaboration skills.
• Comfortable working in a fast paced team environment.
• Excellent communication skills, and comfortable assuming leadership within teams and with external CMO’s, CTL’s, and CRO’s.

Experience and Qualifications

• At least 10 years of experience in Biotechnology quality and compliance roles.
• Bachelor’s degree in related Life Sciences, Chemistry or Biological Sciences discipline.
• Masters preferred.